title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups

summary: The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.

ReferenceCitation: Kim YG. Anticoagulation during haemodialysis in patients at high-risk of bleeding. Nephrology (Carlton). 2003 Oct;8 Suppl:S23-7. Review.

ReferenceCitation: European Best Practice Guidelines Expert Group on Hemodialysis, European Renal Association. Section V. Chronic intermittent haemodialysis and prevention of clotting in the extracorporal system. Nephrol Dial Transplant. 2002;17 Suppl 7:63-71.

ReferenceCitation: Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21.

ReferenceCitation: Lohr JW, Schwab SJ. Minimizing hemorrhagic complications in dialysis patients. J Am Soc Nephrol. 1991 Nov;2(5):961-75.

ReferenceCitation: Yixiong Z, Jianping N, Yanchao L, Siyuan D. Low dose of argatroban saline flushes anticoagulation in hemodialysis patients with high risk of bleeding. Clin Appl Thromb Hemost. 2010 Aug;16(4):440-5. doi: 10.1177/1076029609334628. Epub 2009 Oct 14.

ReferenceCitation: Laville M, Dorval M, Fort Ros J, Fay R, Cridlig J, Nortier JL, Juillard L, Dębska-Ślizień A, Fernández Lorente L, Thibaudin D, Franssen C, Schulz M, Moureau F, Loughraieb N, Rossignol P. Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis. Kidney Int. 2014 Dec;86(6):1260-7. doi: 10.1038/ki.2014.225. Epub 2014 Jul 9.

family: Laville

full_name: Maurice Laville

given: Maurice

family: Dorval

full_name: Marc Dorval

given: Marc

family: Fort Ros

full_name: Joan Fort Ros

given: Joan

family: Fay

full_name: Renaud Fay

given: Renaud

family: Cridlig

full_name: Joëlle Cridlig

given: Joëlle

family: Nortier

full_name: Joëlle L. Nortier

given: Joëlle L.

family: Juillard

full_name: Laurent Juillard

given: Laurent

family: Dębska-Ślizień

full_name: Alicja Dębska-Ślizień

given: Alicja

family: Fernández Lorente

full_name: Loreto Fernández Lorente

given: Loreto

family: Thibaudin

full_name: Damien Thibaudin

given: Damien

family: Franssen

full_name: Casper Franssen

given: Casper

family: Schulz

full_name: Michael Schulz

given: Michael

family: Moureau

full_name: Frédérique Moureau

given: Frédérique

family: Loughraieb

full_name: Nathalie Loughraieb

given: Nathalie

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

journal_name: Kidney International

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Rossignol P, Dorval M, Fay R, Ros JF, Loughraieb N, Moureau F, Laville M. Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial. Trials. 2013 Jun 1;14:163. doi: 10.1186/1745-6215-14-163.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

location_country:
Netherlands
Poland
France
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital Universitary German Trias i Pujol


type: EudraCT Number

title: A Phase I, Open, Dose Escalation Trial With BI 836826 in Patients With Advanced Chronic Lymphocytic Leukaemia

summary: Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial. The trial will examine whether monotherapy with BI 836826 is safe and tolerable at escalating dose levels.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Boehringer Ingelheim

location_country: Germany Belgium France

location_facility: CTR Investigation Clinique, onco, Montpellier

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)

summary: Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Attar A, Lémann M, Ferguson A, Halphen M, Boutron MC, Flourié B, Alix E, Salmeron M, Guillemot F, Chaussade S, Ménard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30.

lead_sponsor: Norgine

location_country:
Italy
Sweden
United Kingdom
France
Poland
Germany
Czech Republic

location_facility: Katedra i Klinika Gastroenterologii i Hepatologii


title: An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

summary:
Purpose of the study:

The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.

Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.

Overall, participation in the study will help determine the following:

Find out if patients receiving Sorafenib will live longer
Find out if Sorafenib helps to slow the worsening of kidney cancer
Find out if Sorafenib has an effect on the tumours

design_allocation: Non-Randomized

lead_sponsor: Bayer

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Poland
Belgium
Spain
Denmark
Germany
United Kingdom


title: A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

summary: The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

primary_purpose: Prevention

lead_sponsor: Warner Chilcott

location_country:
Switzerland
France
Argentina
Australia
Germany
United Kingdom
Canada


type: Other Identifier

title: An Open, Randomised, Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus, Mycophenolate Mofetil and Daclizumab Against Tacrolimus, Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation

acronym: TWIST

summary: The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score (SDS) from baseline to end of study as the primary endpoint. The expected advantages are reduced growth suppression, lower incidence of arterial hypertension and post transplant diabetes mellitus (PTDM) and improved lipid metabolism, expressed by lower serum lipid values.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
South Africa
Sweden
United Kingdom
France
Poland
Israel
Romania
Hungary
Belgium
Turkey
Germany
Czech Republic
Taiwan


title: Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer

summary: Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.

lead_sponsor: Eisai Inc.

location_country:
Peru
France
Russian Federation
Argentina
United States
Ukraine


title: A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients

summary:
Glucontrol is a prospective, randomized, controlled, multi-centric study. The present study will compare the effects of two regimens of insulin therapy, respectively titrated to achieve a blood sugar level between 4.4 and 6.1 mmol/l (80 and 110 mg/dl, respectively) and between 7.8 and 10.0 mmol/l (140 and 180 mg/dl, respectively).

This project aims at defining whether a tight glucose control by insulin improves the vital outcome in a mixed population of critically ill patients (around 3000 patients).

Secondary outcome variables will include in-hospital and 28-day mortality, lengths of stays in the Intensive Care Unit (ICU) and in the hospital, length of ICU stay without life-support therapy, number and clinical signs of episodes of hypoglycemia, rates of infections and organ failures, and number of red-cell transfusions.

ReferenceType: derived

ReferenceCitation: Crosara IC, Mélot C, Preiser JC. A J-shaped relationship between caloric intake and survival in critically ill patients. Ann Intensive Care. 2015 Dec;5(1):37. doi: 10.1186/s13613-015-0079-3. Epub 2015 Nov 5.

family: Crosara

full_name: Isabel Carolina Reis Crosara

given: Isabel Carolina Reis

sequence: first

family: Mélot

full_name: Christian Mélot

given: Christian

sequence: additional

family: Preiser

full_name: Jean-Charles Preiser

given: Jean-Charles

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Preiser JC, Devos P, Ruiz-Santana S, Mélot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chioléro R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.

family: Devos

full_name: Philippe Devos

given: Philippe

family: Ruiz-Santana

full_name: Sergio Ruiz-Santana

given: Sergio

family: Annane

full_name: Djillali Annane

given: Djillali

family: Groeneveld

full_name: Johan Groeneveld

given: Johan

family: Iapichino

full_name: Gaetano Iapichino

given: Gaetano

family: Leverve

full_name: Xavier Leverve

given: Xavier

family: Nitenberg

full_name: Gérard Nitenberg

given: Gérard

family: Singer

full_name: Pierre Singer

given: Pierre

family: Wernerman

full_name: Jan Wernerman

given: Jan

family: Joannidis

full_name: Michael Joannidis

location_country: Switzerland Netherlands France Israel Belgium Spain Germany

location_facility: Centre Hospitalier Universitaire de Liège


title: A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.

status: Terminated

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Belgium France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation

status_simplified: Unknown


type: Registry Identifier

title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Pleural Mesothelioma

summary:
Primary Objective:

To determine the antitumor activity of SAR444245 in combination with other anticancer therapies.

Secondary Objectives:

To confirm the dose and to assess the safety profile of SAR444245 when combined with other anticancer therapies.
To assess other indicators of antitumor activity.
To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination with pembrolizumab.
To assess the immunogenicity of SAR444245.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country:
Italy
France
Japan
Australia
Puerto Rico
Spain
United States
Korea, Republic of
Taiwan

location_facility:
Investigational Site Number :2500005
Investigational Site Number :4100002
Investigational Site Number :2500001
Investigational Site Number :7240004
Investigational Site Number :3920002
Investigational Site Number :7240002
Investigational Site Number :7240006
Investigational Site Number :7240005
Investigational Site Number :0360002
Investigational Site Number :3920004
Investigational Site Number :8400004
Investigational Site Number :3920001
Investigational Site Number :7240003
Investigational Site Number :0360001
Investigational Site Number :8400009
Investigational Site Number :3800004
Investigational Site Number :1580005
Investigational Site Number :2500006
Investigational Site Number :8400001
Investigational Site Number :4100001
Investigational Site Number :3800001

status_simplified: Ongoing


title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase II Trial Investigating the Efficacy and Safety of Trimodulin (BT588) as add-on Therapy to Standard of Care in Adult Subjects With Severe COVID-19

acronym: ESsCOVID

summary:
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19.

Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.

status: Active, not recruiting

ipd_sharing: No

lead_sponsor: Biotest

location_country:
Brazil
Russian Federation
France
Spain

location_facility:
Investigational site # 0711
Investigational site # 0709
Investigational site # 5503
Investigational site # 0701
Investigational site # 0708
Investigational Site # 3301
Investigational site # 0706
Investigational site # 5505
Investigational site # 3305
Investigational Site # 3401
Investigational Site # 3402
Investigational site # 0707
Investigational site # 0702
Investigational site # 5501
Investigational Site # 0704
Investigational site # 3304
Investigational site # 5502

intervention_type: Other


title: A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive V937 in Combination with Pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of V937 administered in combination with pembrolizumab.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Peru
Spain
France
Japan
Poland
Israel
Norway
Hungary
Portugal
Germany
Canada
Taiwan

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0161)

location_facility: National Cheng Kung University Hospital ( Site 0142)

location_facility: Princess Margaret Cancer Centre ( Site 0031)

location_facility: National Cancer Center Hospital East ( Site 0166)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0162)

location_facility: Hospital Universitari Vall d Hebron ( Site 0121)

location_facility: National Taiwan University Hospital ( Site 0141)

location_facility: China Medical University Hospital ( Site 0144)

location_facility: Clinica Universitaria de Navarra ( Site 0122)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0072)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 0146)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0032)

location_facility: Centre Hospitalier Lyon-Sud ( Site 0055)

location_facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 0172)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Providence Portland Medical Center ( Site 0001)

location_facility: Universitaetsklinikum Tuebingen ( Site 0171)

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 0191)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0145)

location_facility: Orszagos Onkologiai Intezet ( Site 0070)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 0181


title: A Phase 1b Open-label Study to Investigate the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

summary: The study aims to evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL) and to determine the maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC administered blinatumomab.

primary_purpose: Basic Science

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
Austria
Germany
France
Spain
United States

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Universitaetsklinikum Leipzig Anstalt des oeffentlichen Rechts

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: University of Texas MD Anderson Cancer Center


title: Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL 2

summary: This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who previously participated in the PROPEL study (Protocol QBGJ398-001) for at least 6 months. The study includes dose escalation with extended treatment, and dose expansion.

lead_sponsor: QED Therapeutics, Inc.

location_country:
United States
France
Australia
Spain
Canada
United Kingdom

location_facility: Nemours Alfred I. Dupont Hospital for Children

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Manchester University Children's Hospital


title: A Phase 1b Dose Escalation Study of Abemaciclib in Combination With Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors

summary: The study's purpose is to see if the drug abemaciclib is safe and effective in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult participants with relapsed/refractory solid tumors.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
France
Japan
Belgium
Spain
Germany

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore


location_country: Jordan Netherlands France Norway Belgium Spain

acronym: ALKALINE

location_facility: CHU-UCL Namur - CHU Mont Godinne - UCL Namur

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: Clinica Universidad de Navarra - Clinica Universitaria De Navarra

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinic Universitari de Barcelona

source: euctr

title: Activity of Lorlatinib Based on ALK Resistance Mutations on Blood in ALK Positive NSCLC Patients Previously Treated With 2nd Generation ALK Inhibitor

summary:
This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to.

The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood.

Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors.

The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes.


title: A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma

summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed Refractory Multiple Myeloma (RRMM).

ReferenceCitation: Sanderson MP, Friese-Hamim M, Walter-Bausch G, Busch M, Gaus S, Musil D, Rohdich F, Zanelli U, Downey-Kopyscinski SL, Mitsiades CS, Schadt O, Klein M, Esdar C. M3258 Is a Selective Inhibitor of the Immunoproteasome Subunit LMP7 (β5i) Delivering Efficacy in Multiple Myeloma Models. Mol Cancer Ther. 2021 Aug;20(8):1378-1387. doi: 10.1158/1535-7163.MCT-21-0005. Epub 2021 May 27.

family: Sanderson

full_name: Michael P. Sanderson

given: Michael P.

family: Friese-Hamim

full_name: Manja Friese-Hamim

given: Manja

family: Walter-Bausch

full_name: Gina Walter-Bausch

given: Gina

family: Busch

full_name: Michael Busch

family: Gaus

full_name: Stefanie Gaus

given: Stefanie

family: Musil

full_name: Djordje Musil

given: Djordje

family: Rohdich

full_name: Felix Rohdich

given: Felix

family: Zanelli

full_name: Ugo Zanelli

given: Ugo

family: Downey-Kopyscinski

full_name: Sondra L. Downey-Kopyscinski

given: Sondra L.

family: Mitsiades

full_name: Constantine S. Mitsiades

given: Constantine S.

family: Schadt

full_name: Oliver Schadt

given: Oliver

family: Klein

full_name: Markus Klein

given: Markus

family: Esdar

full_name: Christina Esdar

given: Christina

journal_name: Molecular Cancer Therapeutics

publisher: American Association for Cancer Research (AACR)

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
United States
France

location_facility: Georgetown University Medical Center- Research Parent

location_facility: Centre Hospitalier Regional Universitaire de Lille


title: A First-in-Human Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of JNJ-74699157 in Participants With Advanced Solid Tumors Harboring the KRAS G12C Mutation

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_facility: H. Lee Moffitt Cancer & Research Institute


ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
United States
France
Japan
Malaysia
Thailand
Tunisia
Singapore
Russian Federation
China
Germany
Korea, Republic of
Taiwan

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

title: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of BI 655130 Treatment in Patients With Generalized Pustular Psoriasis (GPP)

summary: To evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have completed previous BI 655130 trials and are qualified for entry in this trial


lead_sponsor: Celgene

location_country:
Italy
United States
Netherlands
France
Belgium
Spain
Germany

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

location_facility: Princess Maxima Center for Pediatric Oncology

title: A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).

summary:
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.

Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, [DLBCL, BL, or PMBCL]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.


title: An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).

summary: The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
Australia
France

location_facility: The University of Texas MD Anderson Cancer Center, Houston, TX

location_facility: The Alfred Hospital Department of Haematology

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Combination Product


intervention_type: Biological

location_country:
South Africa
Peru
Thailand
France
United States

acronym: PNEU-WAY

location_facility: Triple O Research Institute, P.A. ( Site 0011)

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 0041)

location_facility: Research Institute for Health. ( Site 0182)

location_facility: Siriraj Hosp (Prev&Social Med). ( Site 0183)

location_facility: The Crofoot Research Center, Inc. ( Site 0002)

location_facility: Chris Hani Baragwanath Hospital ( Site 0122)

location_facility: Saint Hope Foundation, Inc. ( Site 0009)

title: A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected With HIV (PNEU-WAY)

summary: This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.


ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Sweden
France
Czechia
Greece
Slovakia
Denmark
United Kingdom

location_facility: Fakultni nemocnice Brno Odd. Detska klinika

location_facility: University Hospital of Wales Heath Park Clinical Research Facility

location_facility: Univerzitna Nemocnica Klinika detí a dorastu

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: The Great North Children's Hospital Royal Victoria Infirmary

location_facility: Dept. of Pediatric Oncology/Hematology/Immunology-Skånes Universitetssjukhus

location_facility: Hospices Civils de Lyon - Hôpitaux Est - IHOP

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases

summary: The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)


title: Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

location_country:
United States
Australia
France
Spain

location_facility: Institut Paoli-Calmettes Departement d'Hématologie

location_facility: The University of Texas MD Anderson Cancer Center, Department of Leukemia, Division of Cancer Medicine

location_facility: Hospital Universitario La Fe Hematology Department

location_facility: Hospital Universitario Vall d' Hebron/VHIO Hematology Department

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service

location_facility: Patient Care Location: Smilow Cancer Hospital at Yale

location_facility: Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire

location_facility: The Alfred Hospital Department of Haematology


title: VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

acronym: VMI-CFA

summary: The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

lead_sponsor: ID3 Medical

location_country: Belgium France

location_facility:
ZNA Stuivenberg
CHU de Nantes
CHU de Clermont-Ferrand
Clinique Rhone Durance
AZ Sint-Blasius
OLV Ziekenhuis Aalst
Imelda Hospital

intervention_type: Device


title: A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study of INC280 and PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent or in combination with INC280 administered orally in adult patients with advanced hepatocellular carcinoma (HCC).

ipd_sharing: Undecided

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Hong Kong
France
Korea, Republic of
China
Germany
Canada
Taiwan


title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

ReferenceCitation: Tchétché D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Søndergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.

family: Tchétché

full_name: Didier Tchétché

given: Didier

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Kasel

full_name: A. Markus Kasel

given: A. Markus

family: Schaefer

full_name: Ulrich Schaefer

given: Ulrich

family: Worthley

full_name: Stephen Worthley

given: Stephen

family: Linke

full_name: Axel Linke

given: Axel

family: Abdel-Wahab

full_name: Mohamed Abdel-Wahab

given: Mohamed

family: Le Breton

full_name: Herve Le Breton

given: Herve

family: Søndergaard

full_name: Lars Søndergaard

given: Lars

family: Spence

full_name: Mark S. Spence

given: Mark S.

family: Petronio

full_name: Sonia Petronio

given: Sonia

family: Baumgartner

full_name: Helmut Baumgartner

given: Helmut

family: Hovorka

full_name: Tomas Hovorka

given: Tomas

family: Blanke

full_name: Philipp Blanke

given: Philipp

family: Reichenspurner

full_name: Hermann Reichenspurner

given: Hermann

journal_name: JACC: Cardiovascular Interventions

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Reichenspurner H, Schaefer A, Schäfer U, Tchétché D, Linke A, Spence MS, Søndergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.

journal_name: Journal of the American College of Cardiology

location_country:
Italy
Switzerland
Netherlands
France
Australia
New Zealand
Denmark
Germany
United Kingdom

location_facility: Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania

location_facility: Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH

location_facility: LMU - Klinikum der Universitaet Muenchen

location_facility: Universitair Medical Center (UMC) Utrecht

location_facility: Erasmus University Medical Center Rotterdam


lead_sponsor: Hoffmann-La Roche

location_country:
Netherlands
France
Spain
Denmark
United States
Canada

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Jewish General Hospital / McGill University

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

title: An Open-Label, Multicenter, Dose-Escalation Phase IB Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Selicrelumab (CD40 Agonist) in Combination With Atezolizumab (Anti PD-L1) in Patients With Locally Advanced and/or Metastatic Solid Tumors

summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.


title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3

summary: The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
Netherlands
France
Israel
Germany
United Kingdom
Canada

location_facility: Barts and The London School of Medicine and Dentistry

location_facility: Groupe Hospitalier Bichat Claude Bernard


ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.

family: Katzenschlager

full_name: Regina Katzenschlager

given: Regina

family: Poewe

full_name: Werner Poewe

given: Werner

family: Rascol

full_name: Olivier Rascol

given: Olivier

family: Trenkwalder

full_name: Claudia Trenkwalder

given: Claudia

family: Deuschl

full_name: Günther Deuschl

given: Günther

family: Chaudhuri

full_name: K Ray Chaudhuri

given: K Ray

family: Henriksen

full_name: Tove Henriksen

given: Tove

family: van Laar

full_name: Teus van Laar

given: Teus

family: Lockhart

full_name: Donna Lockhart

given: Donna

family: Staines

full_name: Harry Staines

given: Harry

family: Lees

full_name: Andrew Lees

given: Andrew

journal_name: Parkinsonism & Related Disorders

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.

location_country:
Austria
Netherlands
France
Spain
Denmark
Germany
United Kingdom

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Newcastle University, Clinical Ageing Research Unit (CARU)

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: Medizinische Universität Graz / Univ. Klinik für Neurologie

location_facility: Bispebjerg University Hospital, Movement Disorder Centre

location_facility: Neurologisches Fachkrankenhausfür Bewegungsstörungen / Parkinson

location_facility: Schön Klinik München Schwabing / Neurologie und Klinische Neurophysiologie

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Donauspital / SMZ-Ost, Abteilung für Neurologie, Sekretariat (Stock 1, Ebene 4)

location_facility: CHU Toulouse, Hôpital Purpan, Centre d'Investigation Clinique

title: Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

summary:
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.

The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.


title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

summary: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

ReferenceCitation: Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Iser

full_name: David M Iser

given: David M

family: Zamora

full_name: Francisco-Xavier Zamora

given: Francisco-Xavier

family: Nelson

full_name: Mark Nelson

given: Mark

family: Stephan

full_name: Christoph Stephan

given: Christoph

family: Massetto

full_name: Benedetta Massetto

given: Benedetta

family: Gaggar

full_name: Anuj Gaggar

given: Anuj

family: Ni

full_name: Liyun Ni

given: Liyun

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Brainard

full_name: Diana Brainard

given: Diana

family: Subramanian

full_name: G Mani Subramanian

given: G Mani

family: McHutchison

full_name: John G McHutchison

given: John G

family: Puoti

full_name: Massimo Puoti

given: Massimo

family: Rockstroh

full_name: Jürgen K Rockstroh

given: Jürgen K

journal_name: The Lancet

ReferenceCitation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

family: Stepanova

full_name: Maria Stepanova

given: Maria

family: Sulkowski

full_name: Mark Sulkowski

family: Naggie

full_name: Susanna Naggie

given: Susanna

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

repository_institution: The Pennsylvania State University - CiteSeer X

location_country:
Italy
France
Australia
Spain
Germany
United Kingdom


title: A Phase 1b Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With CD20-Positive B-Cell Non Hodgkin Lymphoma (NHL)

summary: The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Younes A, Thieblemont C, Morschhauser F, Flinn I, Friedberg JW, Amorim S, Hivert B, Westin J, Vermeulen J, Bandyopadhyay N, de Vries R, Balasubramanian S, Hellemans P, Smit JW, Fourneau N, Oki Y. Combination of ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treatment-naive patients with CD20-positive B-cell non-Hodgkin lymphoma: a non-randomised, phase 1b study. Lancet Oncol. 2014 Aug;15(9):1019-26. doi: 10.1016/S1470-2045(14)70311-0. Epub 2014 Jul 17.

family: Younes

full_name: Anas Younes

given: Anas

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Flinn

full_name: Ian Flinn

given: Ian

family: Friedberg

full_name: Jonathan W Friedberg

given: Jonathan W

family: Amorim

full_name: Sandy Amorim

given: Sandy

family: Hivert

full_name: Benedicte Hivert

given: Benedicte

family: Westin

full_name: Jason Westin

given: Jason

family: Vermeulen

full_name: Jessica Vermeulen

given: Jessica

family: Bandyopadhyay

full_name: Nibedita Bandyopadhyay

given: Nibedita

family: de Vries

full_name: Ronald de Vries

given: Ronald

family: Balasubramanian

full_name: Sriram Balasubramanian

given: Sriram

family: Hellemans

full_name: Peter Hellemans

given: Peter

family: Smit

full_name: Johan W Smit

given: Johan W

family: Fourneau

full_name: Nele Fourneau

given: Nele

family: Oki

full_name: Yasuhiro Oki

given: Yasuhiro

journal_name: The Lancet Oncology


title: A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome

summary: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

location_country:
United States
South Africa
Netherlands
France
Spain
Germany
United Kingdom
Canada


title: A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

summary: The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.

ReferenceType: result

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. Epub 2007 Jan 22.

ReferenceCitation: Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.

name: Millennium Pharmaceuticals, Inc.  a wholly owned subsidiary of Takeda Pharmaceutical Company Limited Cambridge Massachusetts USA

family: Suri

full_name: Ajit Suri

given: Ajit

name: Projections Research, Inc.  Phoenixville Pennsylvania USA

family: Mould

full_name: Diane R. Mould

given: Diane R.

family: Song

full_name: Gregory Song

given: Gregory

family: Kinley

full_name: Judith Kinley

given: Judith

name: EMD Serono Inc.  Billerica Massachusetts USA

family: Venkatakrishnan

full_name: Karthik Venkatakrishnan

given: Karthik

journal_name: The Journal of Clinical Pharmacology

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model‐Informed Hypothesis Generation for Pediatric Dosing Regimens

ReferenceCitation: Locatelli F, Mauz-Koerholz C, Neville K, Llort A, Beishuizen A, Daw S, Pillon M, Aladjidi N, Klingebiel T, Landman-Parker J, Medina-Sanson A, August K, Sachs J, Hoffman K, Kinley J, Song S, Song G, Zhang S, Suri A, Gore L. Brentuximab vedotin for paediatric relapsed or refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma: a multicentre, open-label, phase 1/2 study. Lancet Haematol. 2018 Oct;5(10):e450-e461. doi: 10.1016/S2352-3026(18)30153-4.

family: Locatelli

full_name: Franco Locatelli

given: Franco

family: Mauz-Koerholz

full_name: Christine Mauz-Koerholz

given: Christine

family: Neville

full_name: Kathleen Neville

given: Kathleen

family: Llort

full_name: Anna Llort

given: Anna

family: Beishuizen

full_name: Auke Beishuizen

given: Auke

family: Daw

full_name: Stephen Daw

given: Stephen

family: Pillon

full_name: Marta Pillon

given: Marta

family: Aladjidi

full_name: Nathalie Aladjidi

given: Nathalie

family: Klingebiel

full_name: Thomas Klingebiel

given: Thomas

family: Landman-Parker

full_name: Judith Landman-Parker

family: Medina-Sanson

full_name: Aurora Medina-Sanson

given: Aurora

family: August

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

location_country:
Italy
United States
Mexico
Netherlands
France
Spain
Germany
United Kingdom


title: An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

summary: This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.

location_country:
Italy
United States
France
Japan
Belgium
Spain
Germany
Korea, Republic of

location_facility: University of California at Los Angeles UCLA LeConte Location

location_facility: University of Texas/MD Anderson Cancer Center UT SC


title: A Multicenter, Open-label, Dose Ranging Study to Determine the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Intravenously or Subcutaneously to Adult Asthmatic Subjects With Elevated Blood Eosinophil Levels

summary: A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Estonia
Germany
United States
France


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)

summary: A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.

ReferenceCitation: Wong RS, Bakshi K, Brainsky A. Thrombophilia in patients with chronic immune thrombocytopenia. Scand J Clin Lab Invest. 2015 Jan;75(1):13-7. doi: 10.3109/00365513.2014.962597. Epub 2014 Oct 9.

family: Wong

full_name: Raymond S. M. Wong

given: Raymond S. M.

family: Bakshi

full_name: Kalpana Bakshi

given: Kalpana

family: Brainsky

full_name: Andres Brainsky

given: Andres

journal_name: Scandinavian Journal of Clinical and Laboratory Investigation

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
Italy
United States
India
Hong Kong
Pakistan
France
Hungary
Russian Federation
Germany
Czech Republic
Korea, Republic of


title: A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors

summary: The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.

lead_sponsor: Centocor, Inc.

location_country:
France
Belgium
Spain
United States
United Kingdom


title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

summary: The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

ReferenceCitation: Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Pérez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3.

family: Gronchi

full_name: A. Gronchi

given: A.

family: Bui

full_name: B.N. Bui

family: Bonvalot

full_name: S. Bonvalot

given: S.

family: Pilotti

full_name: S. Pilotti

family: Ferrari

full_name: S. Ferrari

family: Hohenberger

full_name: P. Hohenberger

given: P.

family: Hohl

full_name: R.J. Hohl

family: Demetri

full_name: G.D. Demetri

family: Le Cesne

full_name: A. Le Cesne

family: Lardelli

full_name: P. Lardelli

family: Pérez

full_name: I. Pérez

given: I.

family: Nieto

full_name: A. Nieto

family: Tercero

full_name: J.C. Tercero

family: Alfaro

full_name: V. Alfaro

given: V.

family: Tamborini

full_name: E. Tamborini

given: E.

family: Blay

full_name: J.Y. Blay

journal_name: Annals of Oncology

oa_host_type: publisher

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Germany
United States
France


title: A Ph I/IIa Rand Placebo Ctrl, S-Blind Multictr Dose-Esc Study of SC Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Pts With CD4 T Lymphocyte Counts 101-400 Cells-/mm(3) and Plasma HIV RNA Less Than 50 Copies/mL After at Least 12 M of HAART

summary:
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons.

HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study.

Participants have about 10 clinic visits over 3 months. They receive three injections of IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under the skin in the arm or leg. On the day of each injection, the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples. Three additional visits (one every 3 months) may be scheduled.

During the study visits the following may be done:

Medical history, physical examination, blood tests every visit.
Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose), 14 (day of third dose) and 21.
Chest x-ray study on day 21.
Blood sample collections at frequent intervals during the first 96 hours after the first dose administration. A catheter (thin plastic tube) may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks.
Urine tests several times during the study.

ReferenceCitation: Stebbing J, Gazzard B, Douek DC. Where does HIV live? N Engl J Med. 2004 Apr 29;350(18):1872-80. Review.

ReferenceCitation: Battegay M, Nüesch R, Hirschel B, Kaufmann GR. Immunological recovery and antiretroviral therapy in HIV-1 infection. Lancet Infect Dis. 2006 May;6(5):280-7. Review.

ReferenceCitation: Douek DC, Picker LJ, Koup RA. T cell dynamics in HIV-1 infection. Annu Rev Immunol. 2003;21:265-304. Epub 2001 Dec 19. Review.

lead_sponsor: Cytheris SA

location_country:
Italy
United States
Canada
France

location_facility: Hopital Henri Mendor-Service d'Immunologie Clinique

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma

summary: The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.

status: Withdrawn

location_country:
Germany
United States
France
Spain

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.


title: Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

ReferenceCitation: Lutz MP, Van Cutsem E, Wagener T, Van Laethem JL, Vanhoefer U, Wils JA, Gamelin E, Koehne CH, Arnaud JP, Mitry E, Husseini F, Reichardt P, El-Serafi M, Etienne PL, Lingenfelser T, Praet M, Genicot B, Debois M, Nordlinger B, Ducreux MP; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol. 2005 Dec 20;23(36):9250-6.

ReferenceCitation: Lutz MP, Ducreux M, Wagener T, et al.: Docetaxel/gemcitabine or docetaxel/cisplatin in advanced pancreatic carcinoma: a randomized phase II study of the EORTC-GI group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-498, 2002.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Netherlands
France
Poland
Belgium
Egypt
Turkey
Germany
United Kingdom

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Hermann-Holthusen Institute for Radiotherapy

location_facility: Dokuz Eylul University School of Medicine


lead_sponsor: Imara, Inc.

location_country:
Italy
Lebanon
Morocco
Netherlands
France
Malaysia
Greece
Israel
Georgia
Tunisia
Turkey
Denmark
United States
United Kingdom

location_facility: Hospital of the University of Pennsylvania

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Hospital Queen Elizabeth - Kota Kinabalu

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Centre National de Greffe de la Moelle Osseuse

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Amsterdam Universitair Medische Centra - Academisch Medisch Centrum

location_facility: Manchester University NHS Foundation Trust

location_facility: Centre Hôpital Universitaire Farhat Hached

location_facility: Medinvest - Institute of Hematology and Transfusiology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: American Institute of Research - Whittier

title: A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia

summary: A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia


title: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

summary:
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Manoharan G, Grube E, Van Mieghem NM, Brecker S, Fiorina C, Kornowski R, Danenberg H, Ruge H, Thiele H, Lancellotti P, Søndergaard L, Tamburino C, Oh JK, Fan Y, Windecker S. Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study. EuroIntervention. 2020 Nov 20;16(10):850-857. doi: 10.4244/EIJ-D-20-00279.

family: Manoharan

full_name: Ganesh Manoharan

given: Ganesh

family: Grube

full_name: Eberhard Grube

given: Eberhard

family: Van Mieghem

full_name: Nicolas M. Van Mieghem

given: Nicolas M.

family: Brecker

full_name: Stephen Brecker

family: Fiorina

full_name: Claudia Fiorina

given: Claudia

family: Kornowski

full_name: Ran Kornowski

given: Ran

family: Danenberg

full_name: Haim Danenberg

given: Haim

family: Ruge

full_name: Hendrik Ruge

given: Hendrik

family: Thiele

full_name: Holger Thiele

given: Holger

family: Lancellotti

full_name: Patrizio Lancellotti

given: Patrizio

family: Søndergaard

full_name: Lars Søndergaard

given: Lars

family: Tamburino

full_name: Corrado Tamburino

given: Corrado

family: Oh

full_name: Jae K. Oh

given: Jae K.

family: Fan

full_name: Yunhua Fan

given: Yunhua

family: Windecker

full_name: Stephan Windecker

given: Stephan

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
Austria
Switzerland
Netherlands
United Kingdom
Finland
France
Israel
Norway
Belgium
Spain
Denmark
Germany
Slovenia

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Hospital Universitario Central de Asturias

location_facility: Royal Victoria Hospital - Belfast Health and Social Care Trust

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: AOU Presidio Gaspare Rodolico Policlinico


ReferenceCitation: Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jiménez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.

name: Indiana Hemophilia and Thrombosis Center, Indianapolis, IN;

family: Shapiro

full_name: Amy D. Shapiro

given: Amy D.

name: Division of Hematology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand;

family: Angchaisuksiri

full_name: Pantep Angchaisuksiri

given: Pantep

name: Center for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden;

family: Astermark

full_name: Jan Astermark

given: Jan

name: Department of Hematology, Belfast Health and Social Care Trust, Belfast, United Kingdom;

family: Benson

full_name: Gary Benson

given: Gary

name: Center for Bleeding Disorders and Coagulation, Department of Oncology, Careggi University Hospital, Florence, Italy;

family: Castaman

full_name: Giancarlo Castaman

given: Giancarlo

name: Katharine Dormandy Hemophilia Centre and Thrombosis Unit, Royal Free London NHS Foundation Trust, London, United Kingdom;

family: Chowdary

full_name: Pratima Chowdary

given: Pratima

name: Institute of Clinical Hemostaseology and Transfusion Medicine, Saarland University and University Hospital, Homburg, Saar, Germany;

family: Eichler

full_name: Hermann Eichler

given: Hermann

name: Haematology Department, La Paz University Hospital, Universidad Autónoma Madrid, Madrid, Spain;

family: Jiménez-Yuste

full_name: Victor Jiménez-Yuste

given: Victor

name: Department of Hematology, Ege University Children’s Hospital, Izmir, Turkey;

family: Kavakli

full_name: Kaan Kavakli

given: Kaan

name: Department of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan;

family: Matsushita

full_name: Tadashi Matsushita

given: Tadashi

name: The Hemophilia Centre, Department of Haematology, Aarhus University, Aarhus, Denmark;

family: Poulsen

full_name: Lone Hvitfeldt Poulsen

given: Lone Hvitfeldt

name: Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN;

family: Wheeler

full_name: Allison P. Wheeler

given: Allison P.

name: Hemostasis and Thrombosis Center, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA;

family: Young

full_name: Guy Young

given: Guy

name: Department of Haematology, and Haemophilia and Thrombosis Unit, University Hospital Centre Zagreb, Zagreb, Croatia;

name: School of Medicine, University of Osijek, Osijek, Croatia;

name: School of Medicine, University of Zagreb, Zagreb, Croatia; and

family: Zupancic-Salek

full_name: Silva Zupancic-Salek

given: Silva

name: Department of Molecular Hemostasis, Institute of Experimental Hematology and Transfusion Medicine, University Clinic, Bonn, Germany

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

journal_name: Blood

evidence: open (via free article)

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
United States
Sweden
France
Japan
Thailand
Spain
Turkey
Germany
United Kingdom
Ukraine

title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.


lead_sponsor: Sanofi

location_country:
Italy
Germany
Finland
France
Czechia
Bulgaria
Argentina
Russian Federation
Spain
Canada
United Kingdom

location_facility:
Investigational Site Number :8260034
Investigational Site Number :7240052
Investigational Site Number :6430062
Investigational Site Number :7240053
Investigational Site Number :6430065
Investigational Site Number :2760061
Investigational Site Number :8260031
Investigational Site Number :2500040
Investigational Site Number :2030042
Investigational Site Number :2500042
Investigational Site Number :2760064
Investigational Site Number :1000001
Investigational Site Number :3800054
Investigational Site Number :2760063
Investigational Site Number :1240110
Investigational Site Number :6430063
Investigational Site Number :3800052
Investigational Site Number :6430001
Investigational Site Number :0320004
Investigational Site Number :2760060
Investigational Site Number :2460040
Investigational Site Number :7240051
Investigational Site Number :7240050
Investigational Site Number :2500041
Investigational Site Number :8260033
Investigational Site Number :2760065
Investigational Site Number :2760062
Investigational Site Number :3800051

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population.

Secondary Objective:

To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.


title: A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.

ReferenceCitation: Azaro A, Massard C, Tap WD, Cassier PA, Merchan J, Italiano A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of the Notch inhibitor crenigacestat (LY3039478) in combination with other anticancer target agents (taladegib, LY3023414, or abemaciclib) in patients with advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1089-1098. doi: 10.1007/s10637-021-01094-6. Epub 2021 Mar 8.

family: Azaro

full_name: Analia Azaro

given: Analia

family: Massard

full_name: Christophe Massard

given: Christophe

family: Tap

full_name: William D. Tap

given: William D.

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

family: Merchan

full_name: Jaime Merchan

given: Jaime

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Anderson

full_name: Bailey Anderson

given: Bailey

family: Yuen

full_name: Eunice Yuen

given: Eunice

family: Yu

full_name: Danni Yu

given: Danni

family: Oakley

full_name: Gerard Oakley

given: Gerard

suffix: III

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

family: Pant

full_name: Shubham Pant

given: Shubham

journal_name: Investigational New Drugs

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
United States
France
Spain

location_facility: University of Texas MD Anderson Cancer Center


title: Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment

summary: A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

lead_sponsor: Cardionovum GmbH

location_country: Germany Belgium France

location_facility:
UZ Leuven
CH Mont-de-Marsan
Jessa hospital
ZNA Stuivenberg
Klinikum Arnsberg
CHU Cermont-Ferrand
CHU Bordeaux
AZ Sint-Jan
ZOL (Ziekenhuis Oost-Limburg)


location_country:
Italy
United States
France
Israel
Spain
Germany
United Kingdom

acronym: iMATRIXcobi

location_facility: University of Texas Health Science Center at San Antonio

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

title: A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

ReferenceCitation: Vij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martínez-López J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22.

family: Vij

full_name: Ravi Vij

given: Ravi

family: Nath

full_name: Rajneesh Nath

given: Rajneesh

family: Afar

full_name: Daniel E.H. Afar

given: Daniel E.H.

family: Mateos

full_name: María-Victoria Mateos

given: María-Victoria

family: Berdeja

full_name: Jesús G. Berdeja

given: Jesús G.

family: Raab

full_name: Marc S. Raab

given: Marc S.

family: Guenther

full_name: Andreas Guenther

given: Andreas

family: Martínez-López

full_name: Joaquín Martínez-López

given: Joaquín

family: Jakubowiak

full_name: Andrzej J. Jakubowiak

given: Andrzej J.

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Weisel

full_name: Katja Weisel

given: Katja

family: Wong

full_name: Shekman Wong

given: Shekman

family: Gulbranson

full_name: Scott Gulbranson

given: Scott

family: Sheridan

full_name: James P. Sheridan

given: James P.

family: Reddy

full_name: Anita Reddy

given: Anita

family: Paiva

full_name: Bruno Paiva

given: Bruno

family: Singhal

full_name: Anil Singhal

given: Anil

family: San-Miguel

full_name: Jesús F. San-Miguel

given: Jesús F.

family: Moreau

full_name: Philippe Moreau

given: Philippe

journal_name: Clinical Cancer Research

evidence: open (via free pdf)

publisher_dissemination: American Association for Cancer Research

title: First-in-Human Phase I Study of ABBV-838, an Antibody–Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma

lead_sponsor: AbbVie

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 141534

location_facility: The Sarah Cannon Research Institute /ID# 135814

location_facility: Universitaetsklinikum Heidelberg /ID# 140046

location_facility: CHRU de Lille, Hopital Claude Huriez /ID# 133634

location_facility: Universitaetsklinikum Wuerzburg /ID# 141533

location_facility: University of Michigan Medical Center /ID# 139402

location_facility: CHU de Nantes, Hotel Dieu - HME /ID# 133633

location_facility: Hospital Clinic de Barcelona /ID# 141643

location_facility: Hospital Universitario 12 de Octubre /ID# 140878

location_facility: Clinica Universitaria de Navarra /ID# 141411

location_facility: Hospital Clinico Universitario Salamanca /ID# 140880

location_facility: Washington University School of Medicine /ID# 135708

location_facility: Hospital Universitario de la Princesa /ID# 140881

location_facility: Universitaetklinikum Dresden /ID# 141860

location_facility: The University of Chicago Medical Center /ID# 139403

location_facility: Universitaetsklinikum Tuebingen /ID# 141074

location_facility: CHU de la miletrie, Centre d'investigation clinique /ID# 147542


ReferenceCitation: Niemeyer CM, Flotho C, Lipka DB, Starý J, Rössig C, Baruchel A, Klingebiel T, Micalizzi C, Michel G, Nysom K, Rives S, Schmugge Liner M, Zecca M, Schönung M, Baumann I, Nöllke P, Benettaib B, Biserna N, Poon J, Simcock M, Patturajan M, Menezes D, Gaudy A, van den Heuvel-Eibrink MM, Locatelli F. Response to upfront azacitidine in juvenile myelomonocytic leukemia in the AZA-JMML-001 trial. Blood Adv. 2021 Jul 27;5(14):2901-2908. doi: 10.1182/bloodadvances.2020004144.

name: Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical Center, University of Freiburg, Freiburg, Germany;

name: German Cancer Research Center (DKFZ), Heidelberg, Germany;

family: Niemeyer

full_name: Charlotte M. Niemeyer

given: Charlotte M.

family: Flotho

full_name: Christian Flotho

given: Christian

name: Translational Cancer Epigenomics Section, Division of Translational Medical Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany;

family: Lipka

full_name: Daniel B. Lipka

given: Daniel B.

name: Department of Paediatric Hematology and Oncology, Charles University and University Hospital Motol, Prague, Czech Republic;

family: Starý

full_name: Jan Starý

given: Jan

name: Department of Pediatric Hematology and Oncology, Münster University Children’s Hospital, Münster, Germany;

family: Rössig

full_name: Claudia Rössig

given: Claudia

name: Department of Pediatric Hematology and Immunology, Centre Hospitalier Universitaire (CHU) Paris–Hôpital Universitaire Robert-Debré (Assistance Publique–Hôpitaux de Paris [AP-HP]), Paris, France;

family: Baruchel

full_name: André Baruchel

given: André

name: Department of Pediatrics, Universitätsklinikum Frankfurt, Frankfurt, Germany;

name: German Cancer Consortium (DKTK), Site Frankfurt, Frankfurt, Germany;

family: Klingebiel

full_name: Thomas Klingebiel

given: Thomas

name: Department of Pediatric Sciences, Istituto Giannina Gaslini, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Genoa, Italy;

family: Micalizzi

full_name: Concetta Micalizzi

given: Concetta

name: Pediatrics and Pediatric Oncology, Hôpital de la Timone, Marseilles, France;

family: Michel

full_name: Gérard Michel

given: Gérard

name: Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark;

family: Nysom

full_name: Karsten Nysom

given: Karsten

name: Pediatric Hematology and Oncology, Institut de Recerca, Hospital Sant Joan de Deu de Barcelona, Barcelona, Spain;

family: Rives

full_name: Susana Rives

given: Susana

name: Division of Haematology, Kinderspital Zürich, Zürich, Switzerland;

family: Schmugge Liner

full_name: Markus Schmugge Liner

given: Markus

name: Pediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy;

family: Zecca

full_name: Marco Zecca

given: Marco

name: Faculty of Biosciences, Heidelberg University, Heidelberg, Germany;

family: Schönung

full_name: Maximilian Schönung

given: Maximilian

name: Department of Pathology, Böblingen Hospital, Sindelfingen, Germany;

family: Baumann

full_name: Irith Baumann

given: Irith

family: Nöllke

full_name: Peter Nöllke

given: Peter

name: Formerly Bristol Myers Squibb, Princeton, NJ;

family: Benettaib

full_name: Bouchra Benettaib

given: Bouchra

family: Biserna

full_name: Noha Biserna

given: Noha

family: Poon

full_name: Jennifer Poon

given: Jennifer

name: Celgene Corporation, a Bristol Myers Squibb company, Uxbridge, United Kingdom;

family: Simcock

full_name: Mathew Simcock

given: Mathew

family: Patturajan

full_name: Meera Patturajan

given: Meera

name: Bristol Myers Squibb, San Francisco, CA;

family: Menezes

full_name: Daniel Menezes

given: Daniel

family: Gaudy

full_name: Allison Gaudy

given: Allison

name: Hematology-Oncology, Prinses Máxima Center for Pediatric Oncology/Hematology, Utrecht, The Netherlands;

family: van den Heuvel-Eibrink

full_name: Marry M. van den Heuvel-Eibrink

given: Marry M.

name: Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy; and

name: Department of Pediatrics, Sapienza University of Rome, Rome, Italy

family: Locatelli

full_name: Franco Locatelli

given: Franco

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
France
Czechia
Ireland
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

location_facility: Hematology, Oncology and clinical immunology / Heinrich-Heine-University

location_facility: St. Anna Kinderkrebsforschung, CHILDREN'S CANCER RESEARCH INSTITUTE

title: A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Azacitidine and to Compare Azacitidine to Historical Controls in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia Before Hematopoietic Stem Cell Transplantation

summary:
Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).

Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data.

Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.

Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.


title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

acronym: TiLE

summary: The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

primary_purpose: Other

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Italy
Sweden
Germany
France
Norway
Spain
Denmark
Canada
United Kingdom

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Laboratoire Alphabio & Institut de Médecine de la Reproducti

location_facility: Birmingham Women's Health Care NHS Trust

location_facility: Montichiari Università degli studi di Bresca


title: A Multiarm, Open-label, Phase 1b Study of MLN2480 (an Oral A-, B-, and CRAF Inhibitor) in Combination With MLN0128 (an Oral mTORC 1/2 Inhibitor), or Alisertib (an Oral Aurora A Kinase Inhibitor), or Paclitaxel, or Cetuximab, or Irinotecan, in Adult Patients With Advanced Nonhematologic Malignancies

summary: The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
United States
United Kingdom
France
Spain

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: The University of Texas MD Anderson Cancer Center


title: Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts

acronym: INTEGRATE

summary: The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

ReferenceCitation: Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggmann P, Kunkel J, Keim S, Jäkel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster GR. Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study. Infect Dis Ther. 2017 Jun;6(2):265-275. doi: 10.1007/s40121-017-0158-x. Epub 2017 May 5.

family: Robaeys

full_name: Geert Robaeys

given: Geert

family: Christensen

full_name: Stefan Christensen

given: Stefan

family: Lucidarme

full_name: Damien Lucidarme

given: Damien

family: Arain

full_name: Amber Arain

given: Amber

family: Bruggmann

full_name: Philip Bruggmann

given: Philip

family: Kunkel

full_name: Jan Kunkel

given: Jan

family: Keim

full_name: Sofia Keim

given: Sofia

family: Jäkel

full_name: Martin Jäkel

given: Martin

family: DeMasi

full_name: Ralph DeMasi

given: Ralph

family: Liu

full_name: Chris Liu

given: Chris

family: Lonjon-Domanec

full_name: Isabelle Lonjon-Domanec

given: Isabelle

family: Foster

full_name: Graham R. Foster

given: Graham R.

journal_name: Infectious Diseases and Therapy

license: implied-oa

license_normalized: implied-oa

repository_institution: Queen Mary University of London - Queen Mary Research Online

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Switzerland
Netherlands
France
Belgium
Germany
United Kingdom