title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis

summary: This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

ReferenceCitation: Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.

lead_sponsor: Amgen

location_country:
Germany
United Kingdom
Denmark
Australia
United States
Malaysia
Taiwan
France


type: EudraCT Number

title: A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The "RELEVANCE" Trial (Rituximab Lenalidomide Versus ANy ChEmotherapy)is Being Conducted as Two Companion Studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the Combined Total of 1000 Patients Enrolled in Both Studies Will be Analyzed.

acronym: RELEVANCE

summary: The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, Bachy E, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Le Gouill S, Daguindau N, Guidez S, Pica GM, Garcia-Sancho AM, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Kalung W, Sehn LH, Izutsu K, Cartron G, Gkasiamis A, Crowe R, Xerri L, Fowler NH, Salles G. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R2) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022 Oct 1;40(28):3239-3245. doi: 10.1200/JCO.22.00843. Epub 2022 Aug 10.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH title and first author match)

host_type: repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;digitalcommons.wustl.edu

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Delfau-Larue MH, Boulland ML, Beldi-Ferchiou A, Feugier P, Maisonneuve H, Casasnovas RO, Lemonnier F, Pica GM, Houot R, Ysebaert L, Tilly H, Eisenmann JC, Le Gouill S, Ribrag V, Godmer P, Glaisner S, Cartron G, Xerri L, Salles GA, Fest T, Morschhauser F. Lenalidomide/rituximab induces high molecular response in untreated follicular lymphoma: LYSA ancillary RELEVANCE study. Blood Adv. 2020 Aug 11;4(14):3217-3223. doi: 10.1182/bloodadvances.2020001955.

oa_colors: green gold

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

oa_host_type: publisher

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Germany Italy Portugal Australia Belgium Spain Canada France

location_facility: Atlantic Health Sciences Corp - Saint John Regional Hospital

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Hôpital de l'Enfant-Jesus, CHU de Quebec

location_facility: McGill University Department of Oncology

location_facility: Medizinische Klinik der Universität Tübingen

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut Català d'Oncologia de Girona (ICO Girona)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

summary: To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Carmeli Y, Armstrong J, Laud PJ, Newell P, Stone G, Wardman A, Gasink LB. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016 Jun;16(6):661-673. doi: 10.1016/S1473-3099(16)30004-4. Epub 2016 Apr 20.

ReferenceCitation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Springer-Nature

ReferenceCitation: Mendes RE, Castanheira M, Woosley LN, Stone GG, Bradford PA, Flamm RK. Characterization of beta-Lactamase Content of Ceftazidime-Resistant Pathogens Recovered during the Pathogen-Directed Phase 3 REPRISE Trial for Ceftazidime-Avibactam: Correlation of Efficacy against beta-Lactamase Producers. Antimicrob Agents Chemother. 2019 May 24;63(6):e02655-18. doi: 10.1128/AAC.02655-18. Print 2019 Jun.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

evidence: oa journal (via doaj)

publisher_dissemination: Wiley

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

ReferenceCitation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.

publisher_dissemination: Oxford University Press

ReferenceCitation: Stone GG, Bradford PA, Newell P, Wardman A. In Vitro Activity of Ceftazidime-Avibactam against Isolates in a Phase 3 Open-Label Clinical Trial for Complicated Intra-Abdominal and Urinary Tract Infections Caused by Ceftazidime-Nonsusceptible Gram-Negative Pathogens. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01820-16. doi: 10.1128/AAC.01820-16. Print 2017 Feb.

location_country:
Poland
Russian Federation
Israel
Argentina
Romania
Mexico
United States
Korea, Republic of
Spain
South Africa
Croatia
Turkey
Czechia
Ukraine
Bulgaria
Peru
Philippines
France


title: DF4 Connector System Post-Approval Study

summary: The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
United States
Canada
France

status_simplified: Completed


lead_sponsor: Novartis Pharmaceuticals

summary: To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.

ReferenceCitation: Jankauskiene A, Drozdz D, Wasilewska A, de Paula-Bernardes R, Glazer R, Valentin M, Tan M, Chiang Y, Bapatla K. Efficacy and safety of valsartan in children aged 1-5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase. Curr Med Res Opin. 2021 Dec;37(12):2113-2122. doi: 10.1080/03007995.2021.1982681. Epub 2021 Oct 9.

oa_host_type: closed

publisher_dissemination: Informa

title: A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Open-label Titration Phase

source: euctr

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country: Germany Italy Lithuania Guatemala Poland Hungary Brazil Belgium France

ipd_sharing: Undecided


title: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

summary: The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

lead_sponsor: LEO Pharma

location_country:
Germany
United Kingdom
Australia
Canada
France

location_facility:
Universitätsklinikum Tübingen
UltraNova Skincare
Centre de Recherche Dermatologique
Windsor Clinical Research Inc.
Dermadvances Research
Innovaderm Research Inc.
St John of God Dermatology
SKiN Centre for Dermatology
Durondel C.P. Inc./Dermatology Clinic
Central Manchester University Hosptial
CHU de Nantes
Stratica Medical
Skin Care Centre


acronym: Not applicable

summary: This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

title: A 24-month, Multi-center, Single Arm, Prospective Study to Evaluate Renal Function, Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

design_allocation: Non-Randomized

location_country:
Germany
Italy
Hungary
United Kingdom
Denmark
Australia
Sweden
Belgium
United States
Spain
Canada
France


type: Other Identifier

title: A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms

summary: The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

enrollment_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Australia
Sweden
Austria
United States
Spain
Canada
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: University of Maryland- Biological Sciences

location_facility: Indiana Blood & Marrow Transplantation (IBMT)


lead_sponsor: Forest Laboratories

summary: The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

ReferenceCitation: Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

oa_host_type: repository

unpaywall_oa_status: green

location_facility:
Forest Investigative Site 096
Forest Investigative Site 059
Forest Investigative Site 054
Forest Investigative Site 580
Forest Investigative Site 073
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 802
Forest Investigative Site 097
Forest Investigative Site 378
Forest Investigative Site 576
Forest Investigative Site 116
Forest Investigative Site 578
Forest Investigative Site 704
Forest Investigative Site 804
Forest Investigative Site 131
Forest Investigative Site 118
Forest Investigative Site 078
Forest Investigative Site 155
Forest Investigative Site 626
Forest Investigative Site 098
Forest Investigative Site 067
Forest Investigative Site 085
Forest Investigative Site 101
Forest Investigative Site 063
Forest Investigative Site 382
Forest Investigative Site 119
Forest Investigative Site 730
Forest Investigative Site 053
Forest Investigative Site 095
Forest Investigative Site 080
Forest Investigative Site 057
Forest Investigative Site 702
Forest Investigative Site 072
Forest Investigative Site 452
Forest Investigative Site 091
Forest Investigative Site 005
Forest Investigative Site 021
Forest Investigative Site 703
Forest Investigative Site 081
Forest Investigative Site 453
Forest Investigative Site 329
Forest Investigative Site 065
Forest Investigative Site 100
Forest Investigative Site 026
Forest Investigative Site 023
Forest Investigative Site 077
Forest Investigative Site 062
Forest Investigative Site 105
Forest Investigative Site 069
Forest Investigative Site 068
Forest Investigative Site 090
Forest Investigative Site 092
Forest Investigative Site 001
Forest Investigative Site 136
Forest Investigative Site 141
Forest Investigative Site 028
Forest Investigative Site 123
Forest Investigative Site 082
Forest Investigative Site 526
Forest Investigative Site 676
Forest Investigative Site 401
Forest Investigative Site 071
Forest Investigative Site 801
Forest Investigative Site 056
Forest Investigative Site 052
Forest Investigative Site 728
Forest Investigative Site 086
Forest Investigative Site 803
Forest Investigative Site 075
Forest Investigative Site 029
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 127
Forest Investigative Site 113
Forest Investigative Site 055
Forest Investigative Site 276
Forest Investigative Site 019
Forest Investigative Site 109
Forest Investigative Site 051
Forest Investigative Site 628
Forest Investigative Site 104
Forest Investigative Site 627
Forest Investigative Site 108
Forest Investigative Site 226
Forest Investigative Site 376
Forest Investigative Site 227
Forest Investigative Site 107
Forest Investigative Site 102
Forest Investigative Site 066
Forest Investigative Site 204
Forest Investigative Site 061
Forest Investigative Site 124
Forest Investigative Site 203
Forest Investigative Site 130
Forest Investigative Site 729
Forest Investigative Site 701
Forest Investigative Site 807
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 381
Forest Investigative Site 132
Forest Investigative Site 070
Forest Investigative Site 228
Forest Investigative Site 577
Forest Investigative Site 002

status: Terminated

title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

location_country:
Italy
Poland
Colombia
New Zealand
Hungary
Belgium
United States
Korea, Republic of
Spain
Iceland
South Africa
Ukraine
Canada
Estonia
Serbia
France

status_simplified: Unknown


summary: The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

location_facility:
Forest Investigative Site 096
Forest Investigative Site 059
Forest Investigative Site 054
Forest Investigative Site 073
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 802
Forest Investigative Site 097
Forest Investigative Site 378
Forest Investigative Site 576
Forest Investigative Site 116
Forest Investigative Site 578
Forest Investigative Site 704
Forest Investigative Site 804
Forest Investigative Site 131
Forest Investigative Site 118
Forest Investigative Site 078
Forest Investigative Site 626
Forest Investigative Site 067
Forest Investigative Site 085
Forest Investigative Site 101
Forest Investigative Site 063
Forest Investigative Site 119
Forest Investigative Site 053
Forest Investigative Site 095
Forest Investigative Site 080
Forest Investigative Site 057
Forest Investigative Site 702
Forest Investigative Site 072
Forest Investigative Site 452
Forest Investigative Site 005
Forest Investigative Site 021
Forest Investigative Site 703
Forest Investigative Site 081
Forest Investigative Site 453
Forest Investigative Site 329
Forest Investigative Site 065
Forest Investigative Site 100
Forest Investigative Site 026
Forest Investigative Site 023
Forest Investigative Site 077
Forest Investigative Site 062
Forest Investigative Site 105
Forest Investigative Site 069
Forest Investigative Site 106
Forest Investigative Site 068
Forest Investigative Site 090
Forest Investigative Site 092
Forest Investigative Site 001
Forest Investigative Site 136
Forest Investigative Site 141
Forest Investigative Site 028
Forest Investigative Site 082
Forest Investigative Site 526
Forest Investigative Site 676
Forest Investigative Site 401
Forest Investigative Site 071
Forest Investigative Site 056
Forest Investigative Site 052
Forest Investigative Site 728
Forest Investigative Site 086
Forest Investigative Site 075
Forest Investigative Site 029
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 127
Forest Investigative Site 113
Forest Investigative Site 055
Forest Investigative Site 276
Forest Investigative Site 019
Forest Investigative Site 109
Forest Investigative Site 051
Forest Investigative Site 628
Forest Investigative Site 104
Forest Investigative Site 627
Forest Investigative Site 108
Forest Investigative Site 226
Forest Investigative Site 376
Forest Investigative Site 107
Forest Investigative Site 102
Forest Investigative Site 204
Forest Investigative Site 061
Forest Investigative Site 203
Forest Investigative Site 130
Forest Investigative Site 807
Forest Investigative Site 701
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 381
Forest Investigative Site 132
Forest Investigative Site 070
Forest Investigative Site 228
Forest Investigative Site 577
Forest Investigative Site 002

title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine

location_country:
Italy
Poland
Colombia
New Zealand
Hungary
Belgium
United States
Korea, Republic of
Spain
South Africa
Ukraine
Iceland
Estonia
Serbia
France


title: Evaluation de l’effet anesthésique du protoxyde d’azote dans une population d’opérés recevant une anesthésie totale intraveineuse en « boucle » guidée par l’index bispectral (Effect of nitrous oxide on intra-venous closed-loop anesthesia)

acronym: Drone-Proto

lead_sponsor: Hopital Foch

lead_sponsor_type: academique


title: A Phase I /II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

lead_sponsor: Bristol-Myers Squibb International Corporation

status: Ongoing


title: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors

acronym: GEN1029 Safety Trial in Patients With Malignant Solid Tumors

lead_sponsor: Genmab B.V.


title:
Double-blind, vehicle-controlled, randomized, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution in children and adolescents with moderate to severe scalp alopecia areata

 Étude multicentrique en double aveugle, contre placebo et randomisée, visant à évaluer l’efficacité et l’innocuité de la solution cutanée LH-8 chez les enfants et adolescents atteints d’une pelade du cuir chevelu modérée à sévère

lead_sponsor: Legacy Healthcare (France) SAS


title:
Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)

 Essai multicentrique contrôlé randomisé en double aveugle contre placebo étudiant l’efficacité et la tolérance du védolizumab en prévention de la récidive postopératoire de maladie de Crohn après résection-anastomose iléo-colique (REPREVIO)

acronym:
REPREVIO

 REPREVIO

lead_sponsor: Academic Medical Center Amsterdam


title:
A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy

 Étude multicentrique ouverte, avec bras de contrôle randomisé, portant sur l'efficacité, l'innocuité et la pharmacocinétique de la bérubicine administrée par perfusion intraveineuse à des patients adultes atteints de glioblastome multiforme récidivant (grade IV de l'OMS) après échec du traitement standard de première intention.

lead_sponsor: CNS Pharmaceuticals, Inc.


title: A Phase 1b/2 Multicenter, Open-label, Expansion Study to Assess the Safety and Efficacy of AMG 420 as Monotherapy in Subjects With Relapsed and/or Refractory Multiple  Myeloma

lead_sponsor: Amgen Inc


title: Colchicine Cardiovascular Outcomes Trial (COLCOT)

acronym: COLCOT

lead_sponsor: Montreal Heart Institute


title: A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy

lead_sponsor: University Hospital of Montpellier


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease

lead_sponsor: Kureha Corporation


title:
A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

 Étude comparative de phase III randomisée, en double aveugle, 3 bras parallèles, visant à évaluer l’efficacité et la sécurité d’emploi d’une combinaison fixe de néfopam/paracétamol (comprimé) pris par voie orale dans la douleur modérée à sévère après l’extraction d’une troisième molaire incluse.

acronym: METAPAIN

lead_sponsor: UNITHER Pharmaceuticals


title: SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION

lead_sponsor: F. Hoffmann-La Roche Ltd


title: An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension)

acronym: Atacicept 28063 (RMS) extension study

lead_sponsor: Merck Serono International


title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel- Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis

acronym: VOCAL

lead_sponsor: Aurinia Pharmaceuticals Inc.


title: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Recipients of Autologous Hematopoietic Cell Tranplants (HCTs)

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title:
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1 3 Alterations (CARE)

 Étude en ouvert de Phase 1/2, visant à évaluer la sécurité, la tolérance, la pharmacocinétique et l’activité antitumorale du repotrectinib chez les jeunes adultes et les enfants atteints de tumeurs malignes avancées ou métastatiques porteuses d’altérations ALK, ROS1, ou NTRK1-3 (CARE)

lead_sponsor: Turning Point Therapeutics, Inc. (a wholly owned subsidiary of Bristol Myers Squibb Company)


title:
A Randomized Study  of Paclitaxel – Carboplatin followed by maintenance Niraparib compared to Paclitaxel – Carboplatin – Bevacizumab followed by maintenance Niraparib + Bevacizumab in Patients With Advanced Ovarian Cancer Following a Front-Line Complete Cytoreductive Surgery

 Etude randomisée comparant Paclitaxel-Carboplatine suivi d’une maintenance par Niraparib avec Paclitaxel-Carboplatine-Bevacizumab suivi d’une maintenance par Niraparib + Bevacizumab chez des patientes atteintes d’un cancer de l’ovaire avancé après une chirurgie de cytoréduction initiale complète

lead_sponsor: ARCAGY-GINECO


title: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

acronym: ROSELLA

lead_sponsor: Corcept Therapeutics Incorporated


title: Neoadjuvant Olaparib and Durvalumab for patients with BRCA-associated TripLE Negative Breast Cancer (NOBLE)

acronym: NOBLE

lead_sponsor: European Organisation for Research and Treatment of Cancer (EORTC)


title:
Efficacy of eltrombopag plus lenalidomide combination therapy in patients with IPSS low and intermediate-risk myelodysplastic syndrome with isolated del5q: a multicenter, randomized, double-blind, placebo controlled study

 Etude clinique de la phase II multicentrique randomisée en double-aveugle testant l’efficacité de l’association d’Eltrombopag et de Lénalidomide contre placebo dans les SMD d’IPSS faible ou intermédiaire-1 avec del5q isolée

acronym:
QOL-ONE Rev2MDS

 QOL-ONE Rev2MDS

lead_sponsor: ASSOCIAZIONE QOL-ONE


title: A Phase 2 Randomized, Multi-center, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale

lead_sponsor: Mayne Pharma

status: Prematurely Ended


title: A pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome

acronym: Treat Wolfram

lead_sponsor: University of Birmingham


title: A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.

lead_sponsor: Janssen-Cilag International N.V.


title: A Phase 1 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of DCR-PHXC in Patients with Primary Hyperoxaluria Type 3

lead_sponsor: Dicerna Pharmaceuticals, Inc.


title:
A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Subjects with Advanced Non-small Cell Lung Cancer
 (Master Protocol Revised version 02 dated 27-Jul-2016 + Sub-protocol 01 Revised version 01 dated 08-Apr-2016)

acronym: FRACTION-Lung

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage)

lead_sponsor: Biophytis S.A.


title: A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

acronym: Phase II Study of Pembrolizumab in Subjects with MMRd or MSI-H CRC

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

acronym: EPITOPE

lead_sponsor: DBV TECHNOLOGIES S.A.


title: A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects  with Narcolepsy

lead_sponsor: Jazz Pharmaceuticals, Inc.


title:
A Multicenter, Randomized,  Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20  (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in  Adults with Systemic Sclerosis (SSc).

 Étude de phase II multicentrique, randomisée, menée en ouvert, avec permutation des traitements, visant à évaluer la sécurité d’emploi et la pharmacocinétique de l’IgPro20 (immunoglobuline injectable par voie sous-cutanée, Hizentra®) et de l’IgPro10 (immunoglobuline injectable par voie intraveineuse, Privigen®) chez des patients adultes atteints de sclérodermie systémique (ScS).

lead_sponsor: CSL Behring GmbH


title: An open label, 3-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib in combination with either Chemotherapy or Blinatumomab with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) acute lymphoblastic leukemia (ALL)

lead_sponsor: Cardiff University


title: A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

acronym: Ph 2a, GSK3640254, POC in HIV-1 infected Treatment-naive Adults

lead_sponsor: ViiV Healthcare UK Limited


title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN CISPLATIN-INELIGIBLE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC)

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Randomized, double-blind, placebo controlled, multi-centre, superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain.

acronym: Efficacy and safety study to compare gabapentin as add on to morphine in paediatric patients

lead_sponsor: PHARM – Pharmaceutical Research Management srl


title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)

lead_sponsor: Karyopharm Therapeutics Inc.


title: A Phase 3, Randomized , Open-Label, Multicenter Study of the Efficacy and Safety of Pyrotinib versus Docetaxel in Patients with Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation who progressed on or after Treatment with Platinum Based Chemotherapy

lead_sponsor: Jiangsu Hengrui Medicine Co., Ltd.


title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

acronym: Parsaclisib Rollover study

lead_sponsor: Incyte Corporation


title: An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

lead_sponsor: Minoryx Therapeutics S.L.


title: Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants with Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

acronym: Mogamulizumab Q4week dosing in Participants with R/R CTCL

lead_sponsor: Kyowa Kirin Inc.


title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19

acronym: Phase 3 Double-blind study of AZD7442 or Placebo for Pre-exposure Prophylaxis of COVID-19 in Adults

lead_sponsor: AstraZeneca AB


title:
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

 Étude de phase IIb/III, randomisée, en double aveugle, contrôlée contre placebo, à 2 bras, visant à évaluer l’efficacité et l’innocuité de la nalbuphine en comprimés à libération prolongée dans le prurigo nodulaire pour le soulagement du prurit par modulation des lésions de grattage (étude PRISM - Pruritus Relief through Itch Scratch Modulation)

lead_sponsor: Trevi Therapeutics, Inc.


title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease

lead_sponsor: Forma Therapeutics, Inc.


title: A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, with and without Intermittent LowDose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE).

acronym: VITALIZE

lead_sponsor: IMV Inc.


title: An Open-Label, Single-Arm, Multicenter Study of Intracerebral Administration of Adeno-Associated Viral Vectors Serotype rh10 Carrying the Human N-sulfoglucosamine sulfohydrolase (SGSH) cDNA for the Treatment of Mucopolysaccharidosis Type IIIA

lead_sponsor: Lysogene SA


title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS

 Étude randomisée, en double aveugle, contrôlée contre placebo évaluant l’ALPN-101 dans le lupus érythémateux disséminé (LED)

lead_sponsor: Alpine Immune Sciences, Inc.


title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

lead_sponsor: AlloVir, Inc.


title:
SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients with Severe Eosinophilic Asthma Treated with Benralizumab

 SHAMAL : Étude de Phase IV multicentrique, randomisée, menée en ouvert, avec groupes parallèles, contrôlée versus traitement actif, évaluant la réduction du traitement d’entretien quotidien par ICS/LABA en faveur d'un traitement anti-inflammatoire de crise chez des patients présentant un asthme éosinophilique sévère traités par benralizumab

acronym: SHAMAL


title: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment, With or Without Dialysis

acronym: PHYOX 7: Safety & Efficacy of DCR-PHXC in patients with PH1/2 and ESRD

lead_sponsor: Dicerna Pharmaceuticals Inc

status: Not Authorised


title: An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials

lead_sponsor: Global Blood Therapeutics, Inc.


title:
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with KRT-232 in Subjects with Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)

 Étude de phase 1b/2, multicentrique, en ouvert visant à évaluer l'innocuité et l'efficacité du TL-895 en association avec le KRT-232 chez des patients atteints de leucémie aiguë myéloïde (LAM) FLT3+ récidivante/réfractaire (R/R)

lead_sponsor: Telios Pharma, Inc.


title: A three-period multicenter study, with a randomized withdrawal, double-blinded, placebo-controlled design in Period 2 to evaluate the clinical efficacy, safety and tolerability of MAS825 in NLRC4-GOF patients

lead_sponsor: Novartis Pharma AG


title:
A phase II, multicenter, open-label, randomized-controlled trial evaluating the efficacy and safety of a sequencing schedule of cobimetinib plus vemurafenib followed by immunotherapy with an anti- PD-L1 antibody atezolizumab for the treatment in patients with unresectable or metastatic BRAF V600 mutant melanoma.

 Essai clinique multicentrique, ouvert et randomisé de phase II visant à déterminer l’efficacité et la sécurité d'une thérapie séquentielle à base de cobimétinib et de vémurafénib, suivie d’une immunothérapie par anticorps anti-PD-L1 atézolizumab pour traiter des patients présentant un mélanome inopérable ou métastatique avec mutation BRAFV600.

acronym:
ImmunoCobiVem

 ImmunoCobiVem

lead_sponsor: University Hospital Essen


title:
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in  the Treatment of Adult Subjects with Generalized Pustular Psoriasis

 Extension d’une étude clinique de phase III visant à évaluer l’efficacité et la tolérance à long terme de l’Imsidolimab (ANB019) dans le traitement de patients adultes atteints d’un Psoriasis Pustuleux Généralisé

acronym:
Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis

 Sécurité et efficacité à long terme de l'Imsidolimab sur un Psoriasis Pustuleux Généralisé

lead_sponsor: AnaptysBio Inc.


title:
An Open-Label Extension Study of XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy

 Étude d’extension en ouvert évaluant le XEN496 chez des patients pédiatriques présentant une encéphalopathie épileptique et développementale associée à KCNQ2

acronym: EPIK OLE

lead_sponsor: Xenon Pharmaceuticals Inc.


title: An Open-Label, Multicenter, Long-term Extension Study of Tislelizumab-Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies

lead_sponsor: BeiGene, Ltd.


title: International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia

acronym: Seludex

lead_sponsor: University of Birmingham


title: A Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment followed by surgery versus surgery alone in clinical stage IIIB and IIIC melanoma patients.

acronym: Neoadjuvant L19IL2/L19TNF- Pivotal study

lead_sponsor: Philogen S.p.A.


title: A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet’s Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis

lead_sponsor: Amgen Inc


title: A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)- positive oropharyngeal cancer

acronym: Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)

lead_sponsor: Cardiff University


title:
A randomized, double-blind, placebo-controlled, two parallel groups, international multicenter trial to evaluate the effect of Plerixafor in acute respiratory failure related to COVID-19 (LEONARDO)

 Un essai clinique multicentrique international randomisé, en double aveugle, contrôlé par placebo, à deux groupes parallèles pour évaluer l'effet du plérixafor dans l'insuffisance respiratoire aiguë liée à la COVID-19 (LEONARDO)

acronym: LEONARDO

lead_sponsor: 4Living Biotech SAS


title: A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation

lead_sponsor: FORMA Therapeutics, Inc.


title: An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

acronym: VALE

lead_sponsor: Apellis Pharmaceuticals, Inc.


title: Open-Label Extension Study of JM-010 in Parkinson’s Disease Patients With Dyskinesia

lead_sponsor: Contera Pharma A/S


title: Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)

acronym: NIVO-ALCL

lead_sponsor: Gustave Roussy


title: A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination with Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)

lead_sponsor: Innovent Biologics (Suzhou) Co., Ltd.


title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy

acronym: EMBARK: Evaluation of Maralixibat in Biliary Atresia Response post Kasai

lead_sponsor: Mirum Pharmaceuticals Inc.


title:
A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH)
 The ARMOR Study

lead_sponsor: Galmed Research and Development, Ltd.


title:
Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep

 Étude de phase 2, multicentrique, randomisée, en double aveugle, contrôlée par placebo et en groupes parallèles, visant à évaluer l’efficacité, l’innocuité, la tolérance et la pharmacocinétique du NBI-827104 chez des patients pédiatriques atteints d’encéphalopathie épileptique avec pointes-ondes continues au cours du sommeil

lead_sponsor: Neurocrine Biosciences, Inc.


title: Phase 2 non-randomized, open-label, multi-cohort, multicenter study assessing the clinical benefit of SAR444245 (THOR-707) with or without other anticancer therapies for the treatment of adults and adolescents with relapsed or refractory B cell lymphoma (Pegasus Lymphoma 205)

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: Exploratory study of the safety, tolerability and efficacy of nangibotide in mechanically ventilated patients with COVID-19 and features of systemic inflammation - A randomized, double-blind, placebo-controlled study with adaptive features.

lead_sponsor: INOTREM S.A.


title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in subjects with Alcoholic Hepatitis

lead_sponsor: DURECT Corporation


title: A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich ataxia (MOVE-FA)

acronym: MOVE-FA

lead_sponsor: PTC Therapeutics, Inc.


title:
A Phase III study of JR-141 in Mucopolysaccharidosis type II (Hunter Syndrome) patients.

 Étude de Phase III du JR-141 chez des patients atteints d’une mucopolysaccharidose de type 2 (Maladie de Hunter).

lead_sponsor: JCR Pharmaceuticals Co., Ltd.


title:
A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

 Étude multicentrique, randomisée, en double aveugle, contrôlée contre placebo visant à évaluer l'enzastaurine dans la prévention des événements artériels chez des patients atteints de syndrome d'Ehlers-Danlos vasculaire (SEDv) confirmé par la détection de mutations du gène COL3A1, suivie d'une extension en ouvert (EO)

acronym: PREVEnt (Prevention of Rupture with Enzastaurin in Vascular Ehlers-Danlos Syndrome Trial)

lead_sponsor: Aytu BioPharma, Inc.


title: Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects

lead_sponsor: Belite Bio, Inc


title: A prospective randomized, double-blind, placebo-controlled, multi-center phase IIb study to evaluate the efficacy and safety of mocravimod in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT)

lead_sponsor: Priothera S.A.S.


title: A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED)

lead_sponsor: Pierre Fabre Médicament


title:
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

 Étude d'extension du Tazemetostat (TRuST) : une étude d'extension en ouvert

lead_sponsor: Epizyme, Inc.


title: An open label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with advanced non-small cell lung cancer.

acronym: ATX-NS-001 - ATL001 for the Treatment of Non-Small Cell Lung Cancer

lead_sponsor: Achilles Therapeutics Limited


title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to
 Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

lead_sponsor: Incyte Corporation


title: A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old

acronym: IsoCOMFORT study

lead_sponsor: Sedana Medical AB


title:
OPEN LABEL, MULTICENTER PHASE II STUDY OF THE C5A-ANTIBODY IFX-1 ALONE OR IFX-1 + PEMBROLIZUMAB IN PATIENTS WITH PD-1- OR PD-L1-RESISTANT/REFRACTORY LOCALLY ADVANCED OR METASTATIC CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)

 Étude de phase 2, multicentrique, en ouvert visant à évaluer l’IFX-1, un anticorps anti-C5a, administré en monothérapie ou en association avec le pembrolizumab chez des patients présentant un carcinome épidermoïde cutané (CEC) localement avancé ou métastatique résistant/réfractaire aux anticorps anti-PD-1 ou anti-PD-L1

lead_sponsor: InflaRx GmbH


title:
A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchenne muscular dystrophy

 Etude en 2 parties, en ouvert, de transfert de gène par voir systémique, évaluant la sécurité et l'expression de RO7494222 (SRP-9001) chez l'enfant âgé de moins de quatre ans présentant une dystrophie musculaire de Duchenne

acronym: ENVOL

lead_sponsor: F. Hoffmann-La Roche Ltd


title: An open-label, multicenter, roll-over study for patients who have completed a prior Novartis-sponsored sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with sabatolimab

lead_sponsor: Novartis Pharma AG


title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

lead_sponsor: AstraZeneca AB


title:
A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

 Étude de phase III randomisée, multicentrique, en ouvert portant sur le traitement de première intention par cellules stromales mésenchymateuses MC0518 par rapport au meilleur traitement disponible chez des patients adultes ou adolescents présentant la forme aiguë de la maladie du greffon contre l'hôte réfractaire aux stéroïdes, suite à une greffe de cellules souches hématopoïétiques allogéniques (étude IDUNN)

acronym: IDUNN

lead_sponsor: medac Gesellschaft für klinische Spezialpräparate mbH


title:
A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy

 Étude de phase III évaluant le XEN496 en traitement adjuvant chez des patients pédiatriques atteints d’encéphalopathie épileptique et développementale associée à KCNQ2

acronym: EPIK

lead_sponsor: Xenon Pharmaceuticals Inc.


title:
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,
 PLACEBO-CONTROLLED PHASE 3 STUDY WITH
 OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY
 AND SAFETY OF INEBILIZUMAB IN ADULTS WITH
 MYASTHENIA GRAVIS

acronym: Myasthenia Gravis INebilizumab Trial (MINT)

lead_sponsor: Viela Bio, Inc.


title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)

acronym: Meteoroid


title: A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months

lead_sponsor: Dova Pharmaceuticals, Inc.


title: Pulmonary vein isolation with versus without continued antiarrhythmic drug treatment in subjects with persistent atrial fibrillation: a prospective multi-centre randomized controlled clinical study (POWDER-AF2 study)

lead_sponsor: AZ Sint-Jan Brugge-Oostende AV


title:
MOUNTAINEER: A Phase 2, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer

 MOUNTAINEER : Étude de phase 2, en ouvert portant sur le tucatinib associé au trastuzumab chez des patients atteints de cancer colorectal métastatique HER2+

lead_sponsor: Seattle Genetics, Inc.


title: A Phase 2 Study of Nivolumab in Combination with Either Rucaparib, Docetaxel, or Enzalutamide in Men with Castration-resistant Metastatic Prostate Cancer

acronym: CheckMate 9KD: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9KD

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Long-Term Follow-Up (LTFU) of Participants Treated with GSK Adoptive Cell Therapies

acronym: Adoptive cell therapy LTFU study

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with a Tyrosine Kinase Inhibitor (TKI) in Patients with Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

lead_sponsor: Kartos Therapeutics, Inc.


title:
A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered with First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients with Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)

 Étude de phase 2, randomisée, ouverte, évaluant le trilaciclib administré avec une chimiothérapie à base de platine en première ligne et un traitement d’entretien par avélumab chez des patients ayant un carcinome urothélial localement avancé ou métastatique non traité (PRESERVE 3)

acronym:
PRESERVE 3

 PRESERVE 3

lead_sponsor: G1 Therapeutics, Inc.


title: A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)

lead_sponsor: Madrigal Pharmaceuticals, Inc.


title: Phase 1/2 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2002 in Adults with Hereditary Angioedema (HAE)

lead_sponsor: Intellia Therapeutics, Inc.


title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients with Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as High or Intermediate Risk by a 14-Gene Prognostic Assay

lead_sponsor: IFCT


title: Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): An international investigator-led phase III multi-arm multistage randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse

acronym: RAMPART

lead_sponsor: University College London


title:
A multicenter, open-label, metabolic balance study to evaluate the effects of apraglutide on intestinal absorption in adult subjects with short bowel syndrome, intestinal failure (SBS-IF), and colon-in-continuity (CIC)

 Étude de l’équilibre métabolique multicentrique en ouvert visant à évaluer les effets de l’apraglutide sur l’absorption intestinale chez des patients adultes présentant un syndrome du grêle court avec une insuffisance intestinale (SGC-II) et un côlon en continuité (CEC).

lead_sponsor: VectivBio AG


title:
PHASE II STUDY OF IBERDOMIDE (CC220) MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

 ÉTUDE DE PHASE II DE L'IBERDOMIDE (CC220) EN TRAITEMENT DE MAINTENANCE APRÈS AUTOGREFFE DE CELLULES SOUCHES CHEZ DES PATIENTS ATTEINTS DE MYÉLOME MULTIPLE NOUVELLEMENT DIAGNOSTIQUÉ

lead_sponsor: European Myeloma Network – EMN


title: A Phase 2, multicenter, randomized study of trastuzumab deruxtecan in subjects with HER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC) [DESTINY-Lung02]

lead_sponsor: Daiichi Sankyo, Inc.


title: Etude ATOLL . Etude internationale, multicentrique, visant à comparer l'utilisation de l'enoxaparine IV versus héparine standard IV chez les sujets présentant un infarctus du myocarde aigu et nécessitant l'intervention coronarienne  percutanée primaire

acronym: ATOLL

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Open label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients

 Essai prospectif multicentrique en ouvert pour caractériser la pharmacocinétique et la pharmacodynamique de Cufence (dichlorhydrate de trientine) et d’en étudier l’efficacité et l’innocuité chez les patients atteints de la maladie de Wilson

acronym: TR-004 UNITED Study

lead_sponsor: Univar Solutions, B.V.


title: An open-label study to provide berotralstat access to subjects with type 1 and 2 hereditary angioedema who were previously enrolled in berotralstat studies

lead_sponsor: BioCryst Pharmaceuticals Inc


title: A randomized, double blind, placebo controlled, multicenter study to determine the effect of QVA149 on mean 24-hours heart rate in patients with Chronic Obstructive Pulmonary Disease (COPD)

lead_sponsor: Novartis Pharma AG


title: Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom’s Macroglobulinemia: A multicenter Trial of the European Myeloma Network

acronym: protocole BDR

lead_sponsor: Centre Hospitalier de Lens


title: A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies.

lead_sponsor: Schering-Plough Research Institute, A Division of Schering Corporation


title: EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with etoposide, or masitinib in combination with irinotecan in patients with advanced hepatocellular carcinoma and who relapsed after a first line therapy with sorafenib.

lead_sponsor: AB Science


title: A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS AND/OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: An adaptive Phase 2/3, randomized, open-label study assessing efficacy and safety of hydroxychloroquine for hospitalized patients with moderate to severe COVID-19

lead_sponsor: sanofi-aventis recherche & développement


title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: Proof of Concept study of the efficacy and tolerability of a 4-week treatment with F13640 in patients in whom the adaptation of opioid therapy of cancer pain has failed. A prospective, multinational, multicentre, randomised, double-blind, placebo-controlled study.


title: LONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR.  A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS,  DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN

acronym: Not applicable


title: A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

lead_sponsor: Theratechnologies Inc.


title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with Alendronate

acronym: Odanacatib Study in Patients Previously Treated with Alendronate

lead_sponsor: Merck & Co. Inc


title: An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine

lead_sponsor: Novartis Pharma Services AG


title: An Investigator-initiated study on rFVIIa prophylaxis in children with haemophilia A and inhibitors

acronym: ENJOIH 01

lead_sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico


title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: A Randomized Discontinuation Phase II Trial of Deforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients with KRAS Mutations

lead_sponsor: Merck & Co. Inc.


title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients

acronym: Phase II AK Study

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: Safety of SCH 527123 in Subjects with Neutrophilic Asthma

lead_sponsor: Schering-Plough Research Institute, a Division of Schering Corporation


title: A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years

acronym: DPM-CF-204 mannitol in CF aged 6-17 years

lead_sponsor: Pharmaxis Ltd.


title: An international multicentre, randomized, parallel group, double-blind trial to evaluate different dose combinations of lercanidipine and enalapril in comparison with each component administered alone and with placebo in patients with essential hypertension.

lead_sponsor: Recordati S.p.A.,


title: Open-label, non-controlled, multicenter long-term study to investigate the safety and efficacy of Xeomin® (incobotulinumtoxin A, NT 201) for the treatment of spasticity of the lower limb(s) or of combined spasticity of upper and lower limb in children and adolescents (age 2 - 17 years) with cerebral palsy

lead_sponsor: Merz Pharmaceuticals GmbH


title: A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and the pharmacokinetics of GSK221149A administered orally in healthy, pregnant females, with uncomplicated pre-term labor between 30 0/7 – 35 6/7 weeks gestation.

lead_sponsor: GlaxoSmithKline Research and Development


title: A 28 week extension to a 24 week multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of vildagliptin (50 mg qd) versus placebo in patients with type 2 diabetes and moderate or severe renal insufficiency

lead_sponsor: Novartis Services AG


title: An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy

lead_sponsor: Shionogi USA, Inc.


title: CLINICAL EFFICACY AND SAFETY OF TAZAROTENE CREAM 0.05% IN THE INITIAL AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)

lead_sponsor: Orfagen


title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection

acronym: MK-3682B in Hepatitis C Virus (HCV) Genotype 3 (GT3) participants

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title:
Additive Effect of Twice Daily Brinzolamide 1% /Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

 Effet additif d'une administration deux fois par jour d'une association fixe de brinzolamide 1%/brimonidine 0.2% associé à un traitement par un analogue de la prostaglandine.

acronym: Simbrinza BID as an Adjunctive to Prostaglandin Analogue (PGA)

lead_sponsor: Alcon Research, Ltd.


title:
International, multicentre, efficacy and safety study of I10E in the
 maintenance treatment of patients with Chronic Inflammatory
 Demyelinating Polyradiculoneuropathy: Extension of PRISM study
 I10E-1302

acronym: PRISM 2

lead_sponsor: LFB BIOTECHNOLOGIES


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title:
An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

 Étude internationale d'extension à long terme, multicentrique, en ouvert, évaluant l’innocuité de la pommade à la diacéréine 1 % en application locale chez les patients atteints d’épidermolyse bulleuse simple (EBS)

lead_sponsor: Castle Creek Pharmaceuticals, LLC


title: AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC AND 48-WEEK SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2-18 YEARS OF AGE

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017


title: V0251 oral suspension efficacy and tolerance in vestibular neuritis. A randomised double-blind placebo controlled study

lead_sponsor: PIERRE FABRE MEDICAMENT -IRPF- PIERRE FABRE INNOVATION


title: A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with type 2 diabetes and moderate renal insufficiency

lead_sponsor: Novartis Pharma Services AG


title: Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib

lead_sponsor: Gilead Sciences, Inc.


title: RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY  OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A phase III, randomized, double-blind, active-controlled, equivalence clinical trial to investigate the efficacy and safety of a single injection of 100 µg Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation (COS) using daily recombinant FSH (recFSH) as a reference

acronym: Ensure

lead_sponsor: NV Organon


title: A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106.

acronym: Not applicable.


title: FONDAparinux in patients with a plaster CAST (FONDACAST):  A Multicentre, Randomized, Open-label, Controlled, Two-Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Fondaparinux versus Low-molecular-Weight Heparin (Nadroparin), in Patients Requiring Rigid or Semi-rigid Immobilization for at least 21 Days and up to 45 Days because of Isolated Non-surgical Below-Knee Injury

acronym: FONDACAST

lead_sponsor: GlaxoSmithKline R & D


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine

lead_sponsor: Addex Pharma SA


title: A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

acronym: PROTI

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: A randomised, double-blind, placebo-controlled, long-term Phase III study to assess the efficacy and safety of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.

lead_sponsor: Artu Biologicals Europe B.V.


title: A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy


title: OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)

lead_sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA


title:
Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII

 Etude clinique chez des enfants atteints d’hémophilie A sévère et préalablement traités visant à étudier l'immunogénicité, la tolérance et l'efficacité à long terme de Human-cl rhFVIII

lead_sponsor: Octapharma AG


title: Randomised phase II trial of oral vinorelbine and cisplatin followed by maintenance with single agent oral vinorelbine versus gemcitabine and cisplatin followed by maintenance with single agent gemcitabine in first line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type

lead_sponsor: Pierre Fabre Medicament


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title: Phase II study for repeated dosing of the trifunctional bispecific  anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with  HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic  breast cancer (stage IIIb/IV) progressing after endocrine treatment

lead_sponsor: Fresenius Biotech GmbH


title:
A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC

 Essai de phase I NECTAR (Nélarabine, Etoposide et Cyclophosphamide dans les rechutes de LAL-T) : Une étude conjointe de TACL, POETIC et ITCC

acronym:
NECTAR trial

 Etude NECTAR

lead_sponsor: TACL


title: A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.

acronym: GETAID 2014-3 SPARE

lead_sponsor: GETAID


title: Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With Relapsed/Refractory MYC-Altered Diffuse Large B-Cell Lymphoma

lead_sponsor: Curis, Inc.


title: Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with fEcal microbiota transfer (HERACLES)

acronym: HERACLES

lead_sponsor: MaaT Pharma


title: An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes

lead_sponsor: GW Research Ltd


title: Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study "REDUCE"

lead_sponsor: European Organisation for Research and Treatment of Cancer (EORTC)


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development


title: A PHASE IIIB, RANDOMIZED, ACTIVE CONTROLLED OPEN-LABEL STUDY OF SUNITINIB (SUTENT) 37.5 MG DAILY VS IMATINIB MESYLATE 800 MG DAILY IN THE TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMORS (GIST) WHO HAVE HAD PROGRESSIVE DISEASE WHILE ON 400 MG DAILY OF IMATINIB

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: A Phase IIb, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Artery, 24 hour Ambulatory Blood Pressure, Lipids, Lipoproteins and Markers Vascular Inflammation, Oxidation and CV risk in Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children with Attention Impairment Following Cancer Treatment

lead_sponsor: Eisai Limited


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men with Both Erectile Dysfunction and Benign Prostatic Hyperplasia.

acronym: LVHR

lead_sponsor: Eli Lilly and Company


title: Efficacy and Safety comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the Treatment of  Moderate to Severe Acne Vulgaris.

acronym: TEAM - Tetralysal Epiduo = Acne Makeover

lead_sponsor: Galderma Research & Development


title: A randomised, open label, parallel-group, multi-centre trial to compare the efficacy and safety of TachoSil versus standard haemostatic treatment in the cardiovascular surgery

acronym: TachoSil versus standard haemostatis treatment of haemorrhage in cardiovascular surgery

lead_sponsor: Nycomed Danmark ApS


title: A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY AGGRESSIVE NON-HODGKIN’S LYMPHOMA

lead_sponsor: Celgene Corporation


title: Multicenter parallel phase II trial of BI 2536 administered as one hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EORTC Network of Core Institutions (NOCI)

acronym: Phase II trial of BI 2536 in pts with various solid tumors

lead_sponsor: Boehringer Ingelheim France SAS


title: Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multinodular Goiter

lead_sponsor: Genzyme Europe BV


title: An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone

lead_sponsor: AstraZeneca AB


title: CONNECTION: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease

acronym: CONNECTION

lead_sponsor: Medivation, Inc.


title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase

lead_sponsor: Janssen Cilag International NV


title: Evaluation of the effect of 6 months treatment with V0191 on symptoms changes in patients with Mild Cognitive Impairment. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.

lead_sponsor: PIERRE FABRE MEDICAMENT - IDPF


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures.

acronym: ELEVATE

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Subjects Previously Treated With Rituximab

lead_sponsor: Janssen-Cilag International NV


title: A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects with Inadequately Controlled Asthma

lead_sponsor: Amgen Inc


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, COMPARING THE EFFICACY AND TOLERABILITY OF ZIPRASIDONE (ZELDOX®, GEODON®) VS OLANZAPINE (ZYPREXA®) IN THE TREATMENT AND MAINTENANCE OF RESPONSE IN PATIENTS WITH ACUTE MANIA

acronym: ZOOM STUDY: ZIPRASIDONE AND OLANZAPINE’S OUTCOMES IN MANIA

lead_sponsor: Pfizer Ltd - Sandwich Laboratories


title: Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks.

lead_sponsor: Institut de Recherches Internationales Servier


title: An open label, single-arm, baseline-controlled, multicenter study to evaluate the efficacy, safety and immunogenicity of subcutaneous HX575 administered once a week (qw) and once every two weeks (q2w) in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis subjects

acronym: SWEEP Study

lead_sponsor: Hexal AG


title: A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy

acronym: BCDG


title: A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-week treatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers

acronym: SURSMOKE

lead_sponsor: sanofi-aventis recherche et développement


title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy

lead_sponsor: F. Hoffmann-La Roche Ltd


title: 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease

lead_sponsor: Novartis Pharma AG


title: LENS – Long-term Eltrombopag ObservatioNal Study - A long term observational ocular safety study in adults who have received study medication (SB-497115-GR / eltrombopag olamine or placebo) in a phase II or III clinical study evaluating eltrombopag

acronym: LENS


title: Effect of inhalation of a free combination of tiotropium once daily 18 mcg and salmeterol twice daily 50 mcg versus a fixed combination of fluticasone and salmeterol twice daily (500/50 mcg) on static lung volumes and exercise tolerance in COPD patients (a randomized, double-blind, double dummy, 16 (2 x 8) weeks, crossover study)

acronym: Octane

lead_sponsor: Boehringer Ingelheim


title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

lead_sponsor: Eli Lilly and Company Limited


title: A placebo controlled randomized, 12-week, dose-ranging, double-blind study versus placebo using tolterodine as a study calibrator, to evaluate efficacy and safety of SSR240600C in women with overactive bladder including urge urinary incontinence

lead_sponsor: sanofi-aventis recherche & développement


title: Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder.  An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.


title: A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial

acronym: REGARD-PGx

lead_sponsor: Merck Serono S.A. - Geneva


title: A 24 month extension to a 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic® after 3 months), vs. myfortic® plus tacrolimus in de novo renal transplant recipients

lead_sponsor: Novartis Pharma Services AG


title: A Phase II, Randomized, Double-Blinded, Multicenter, Dose Finding Study Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161) when given in combination with Pegasys® and Copegus® versus the currently approved combination of Pegasys® and Copegus® in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 Virus infection

lead_sponsor: F.  Hoffmann-La Roche Ltd


title: A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients.

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.


title: A Randomised, Open-Label Preliminary Study To Assess The Effects Of Etanercept 50 mg Once Weekly For 24 Weeks And Etanercept 50 mg Twice Weekly For 12 weeks Reducing To Etanercept 50 mg Once Weekly For 12 weeks On Nail And Skin Symptoms In Patients With Nail Psoriasis And Plaque Psoriasis.

lead_sponsor: Wyeth Pharmaceuticals France


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE TREATED WITH A CHOLINESTERASE INHIBITOR

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development


title: A PARALLEL-GROUP, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER DOSE RESPONSE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF- 00885706, A 5-HT4 RECEPTOR PARTIAL AGONIST, AS ADD-ON THERAPY TO ESOMEPRAZOLE FOR THE RELIEF OF SYMPTOMS IN SUBJECTS WITH GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) WHO HAVE A POOR RESPONSE TO PROTON PUMP INHIBITOR (PPI) TREATMENT

lead_sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK


title: A 12-week treatment, multi-center, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease.


title: Randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenicity of subcutaneous EPO HEXAL vs. ERYPO® in the treatment of anemia associated with chronic renal insufficiency in predialysis patients

lead_sponsor: HEXAL Biotech ForschungsGmbH


title: Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases

lead_sponsor: GUERBET


title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FILIBUVIR PLUS PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN IN TREATMENT NAÏVE, HCV GENOTYPE 1 INFECTED SUBJECTS

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017


title:
A randomized  Discontinuation Study of Brivanib alaninate (BMS-582664) versus Placebo in Subjects with Advanced Tumors.
 Revised protocol 01 incorporating Amendment 02

lead_sponsor: Bristol Myers Squibb International Corporation


title: Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line Regimen

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA


title: A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for  6 months in men with lower urinary tract symptoms(LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia(BPH)

acronym: LVIW


title: A Multicentre, Randomised, Double Blind, Placebo controlled Phase IIb Study to compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of CytoFab™ (AZD9773) in Adult Patients With Severe Sepsis and/or Septic Shock

lead_sponsor: AstraZeneca AB


title: An open label, multinational, multicenter study to evaluate the safety of HX575 recombinant human erythropoietin alfa

lead_sponsor: Hexal AG


title: A Single Arm Multicentre Phase II Study of Panitumumab in Combination with Irinotecan/5-Fluorouracil/Leucovorin in Patients with Metastatic Colorectal Cancer

lead_sponsor: Amgen Inc


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraprostatic Administration of BOTOX® 200 U (Botulinum  Toxin Type A) Purified Neurotoxin Complex to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

lead_sponsor: Allergan Limited


title: Effect of Passive Immunization on the Progression of Alzheimer’s Disease:  LY2062430 versus Placebo

lead_sponsor: Eli Lilly and Company


title: A phase III study of Pomalidomide and low dose Dexamethasone with or without Pembrolizumab (MK3475) in refractory or relapsed and refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

acronym: A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in rrMM

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A phase III study of Lenalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in newly diagnosed and treatment naïve Multiple Myeloma (KEYNOTE 185).

acronym: Study of Lenalidomide and Dexamethasone with or without Pembrolizumab in Multiple Myeloma


title:
An international, multicentre, efficacy and safety study of I10E in
 initial and maintenance treatment of patients with Chronic
 Inflammatory Demyelinating Polyradiculoneuropathy

acronym: PRISM

lead_sponsor: LFB BIOTECHNOLOGIES


title: A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

lead_sponsor: Talecris Biotherapeutics Inc


title: Randomised double blind placebo controlled pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis +/- controlled Asthma

acronym: 2nd pivotal rPhleum

lead_sponsor: Allergopharma Joachim Ganzer KG


title: A multicenter, multinational phase II study to assess the clinical safety and feasibility of T-DM1 sequentially with anthracyline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients with early stage HER2-positive breast cancer.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Paediatric Subjects with Haemophilia A (≤2%) who have Developed High-titre Antibodies to Factor VIII (Factor VIII Inhibitors)

acronym: SWIFT-ITI

lead_sponsor: CSL Behring GmbH


title: A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.

lead_sponsor: ViiV Healthcare UK Ltd


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE)

lead_sponsor: Achaogen, Inc.


title: A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

acronym: SORCE

lead_sponsor: Medical  Research Council


title: A randomized, sham-injection controlled, double-masked, multicenter trial of microplasmin intravitreal injection for treatment of exudative age-related macular degeneration (AMD).

lead_sponsor: ThromboGenics NV


title: A Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab Plus AMG 479 in Subjects With Metastatic Colorectal Carcinoma Expressing Wild Type KRAS and Refractory to Oxaliplatin- or Irinotecan- and Oxaliplatin-containing Regimens to Evaluate Mechanisms of Acquired Resistance to Panitumumab


title:
A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.

 Etude de phase 2, prospective, multicentrique, en ouvert, avec allocation centralisée, contrôlée, visant à comparer l'efficacité et la tolérance de masitinib en association avec gemcitabine versus gemcitabine seule, chez des patientes atteintes d'un cancer de l’ovaire épithélial métastatique/avancé en 2ème ligne de traitement réfractaire à une première ligne de traitement avec sels de platine ou en 3ème ligne de traitement

lead_sponsor: AB Science


title: Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.

lead_sponsor: PIERRE FABRE MEDICAMENT


title:
A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents.

 Une étude de 12 semaines, en double aveugle, groupes paralèlles, 1:1, randomisée versus placebo de l'efficacité et la tolérance de la rispéridone chez les enfants et adolescents de 5,0 à 17,9 ans ayant un trouble des conduites selon les critères du DSM-IV.

acronym:
CONCA

 CONCA

lead_sponsor: Radboud University Medical Centre Nijmegen


title: A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

lead_sponsor: Tibotec Pharmaceuticals Ltd


title: A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc


title:
A Prospective, Open-label, Long-term Safety and Efficacy Study of
 Teduglutide in Pediatric Patients with Short Bowel Syndrome Who
 Completed TED-C14-006 or SHP633-301

 Original PIP P/238/2010

lead_sponsor: Shire Human Genetic Therapies, Inc.


title: An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.


title: A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML

acronym: CLARA-DNX

lead_sponsor: Hospices Civils de Lyon


title: A Randomized, Double-Blind, Placebo-Controlled, Polysomnography plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults with Chronic Insomnia

lead_sponsor: Takeda Global Research & Development Centre (Europe) Ltd.


title: Randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed dose study comparing the efficacy and safety of Lu AA21004 in acute treatment of major depressive disorder in elderly patients

acronym: Not applicable

lead_sponsor: H. Lundbeck A/S


title: Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant comination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour.

acronym: FACT

lead_sponsor: AstraZeneca AB


title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care

lead_sponsor: Kaleido Biosciences


title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™)

acronym: CLEAREST™-TRAIL

lead_sponsor: Merck Serono International S.A.


title: A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL GROUP, MULTI-CENTRE PHASE IIB DOSE-FINDING STUDY OF M516102 IN THE TREATMENT OF PRURITUS ASSOCIATED WITH ATOPIC DERMATITIS.

lead_sponsor: Maruho Co., Ltd


title: CONNECTION PLUS:  An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease

acronym: CONNECTION Plus

lead_sponsor: Medivation, Inc.


title: Evaluation of Belatacept as First-line Immunosuppression in De Novo Liver Transplant Recipients  Revised Protocol Number 01, incorporating Amendment 02 (version 1.0 dated 22-Oct-07)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens


title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 with Exemestane or Fulvestrant in Postmenopausal Women with Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Amgen Inc.


title: A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton’s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma

lead_sponsor: Pharmacyclics LLC


title: Phase II Study of ZK 219477 in patients with recurrent glioblastoma

lead_sponsor: European Organisation for Research and Treatment of Cancer