title: A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR

lead_sponsor: Pfizer

ReferenceCitation: Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.

ReferenceCitation: Verschuur AC, Bajčiová V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20.

location_country:
United States
France
Czechia

location_facility: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles

summary: Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.


title: A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Jennerex Biotherapeutics

location_country:
United States
Canada
France

location_facility: Ottawa Hospital and Research Institute (OHRI)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

location_country:
Croatia
Spain
Greece
Austria
Australia
Netherlands
Canada
Czech Republic
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
South Africa
Japan
Germany
Bulgaria

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Suncoast Endoscopy Center (Colonoscopy Only)

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Digestive Diseases Institute, Shaare Zedek Medical Center

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,

location_facility: University Hospitals Case Medical Center

location_facility: Gasteroenterology Consultants of Clearwater

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Medical Diagnostic Imaging (MDI) X-ray and MRI only

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

location_facility: Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: University Hospitals Westlake Medical Center

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Clinical Research Institute of Michigan LLC

location_facility: Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course

location_facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Shands Hospital at the University of Florida

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: Severance Hospital, Yeonsei University Health System

location_facility: Advanced Clinical Research Institute - Phase 1, LLC

location_facility: University of Kentucky Chandler Medical Center

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium

location_facility: Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)

location_facility: Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre

location_facility: Endoscopy Center of the Rockies - Longmont

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"

location_facility: Heartland Medical Research, Inc (Administrative Only)

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: State Institution "Institute of Gastroenterology of AMS of Ukraine"

location_facility: Charlotte Gastroenterology and Hepatology, PLLC

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: London Health Sciences Centre - University Hospital

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: University Hospitals Chagrin Highlands Health Center

location_facility: Medical Research Center of Connecticut, LLC

intervention_type: Drug


status: Terminated

acronym: FUTURE 4

title: Multicenter, Double-blind, Placebo-controlled, Randomized, Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn (PPHN)

lead_sponsor: Actelion

source: euctr

ReferenceCitation: Steinhorn RH, Fineman J, Kusic-Pajic A, Cornelisse P, Gehin M, Nowbakht P, Pierce CM, Beghetti M; FUTURE-4 study investigators. Bosentan as Adjunctive Therapy for Persistent Pulmonary Hypertension of the Newborn: Results of the Randomized Multicenter Placebo-Controlled Exploratory Trial. J Pediatr. 2016 Oct;177:90-96.e3. doi: 10.1016/j.jpeds.2016.06.078. Epub 2016 Aug 5.

location_country:
Poland
United Kingdom
Russian Federation
Australia
Czech Republic
Switzerland
Korea, Republic of
United States
France
Singapore
Belgium
Germany

location_facility: Liverpool Women's NHS Foundation Trust - Site 1702

location_facility: Instytut Centrum Zdrowia Matki Polki - Site 2106

location_facility: The Royal Children's Hospital, Department of Neonatology - Site 3001

location_facility: Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Neonatologie - Site 1201

location_facility: Klinikum der Universität zu Köln Klinik und Poliklinik für Kinder-und Jugendmedizin, Dep. Neonatologie u. Pädiatrische Intensivmedizin - Site 1203

location_facility: Centre Hospitalier Universitaire Vaudois Départment Médico-Chirurgical de Pédiatrie / Service de Néonatologie - Site 1901

location_facility: Kantonsspital Luzern, Kinderspital Kinder-Intensivmedizin / Pädiatrie / Neonatologie - Site 1902

location_facility: KK Women's and Children's Hospital - Site 5401

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre - Service de réanimation néonatale - Site 1802

location_facility: Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu - Site 2103

location_facility: Federal State Budgetary Institution "Scientific Center for obstetrics, gynecology and perinatology named after V.I. Kulakov" Ministry of Healthcare of the Russian Federation - Site 2501

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust - Site 1703

location_facility: Všeobecná fakultní nemocnice Klinika dětského a dorostového lékařství - Site 2002

location_facility: Szpital Kliniczny im. ks. Anny Mazowieckiej - Site 2101

location_facility: Hôpital Trousseau - Service de réanimation néonatale et pédiatrique - Site 1804

location_facility: Advocate Lutheran General Div. of Neonatal & Development Medicine - Site 6010

location_facility: Medical University of South Carolina, Pediatric Cardiology - Site 6019

location_facility: Advocate Hope Children's Hospital - Site 6009

location_facility: LURIE CHILDREN'S HOSPITAL OF CHICAGO - Site 6021

location_facility: Fakultní nemocnice v Motole Novorozenecké oddělení - Site 2001

location_facility: Division of Neonatology, Mater Mothers' Hospital, Mater Health Services, Brisbane Ltd. - Site 3003

location_facility: Great Ormond Street Hospital, Paediatric and Neonatal Intensive Care Unit - Site 1700

summary: The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

status_simplified: Unknown


title: A Study to Assess the Safety, Tolerability and Preliminary Efficacy of GSK2251052 in the Treatment of Complicated Intra-abdominal Infection in Adults

summary: This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

study_start_date_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
Russian Federation
Canada
United States
France
Czechia

intervention_type: Other


title: A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

summary:
Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

ReferenceType: result

ReferenceCitation: Jagasia M, Scheid C, Socié G, Ayuk FA, Tischer J, Donato ML, Bátai Á, Chen H, Chen SC, Chin T, Boodée H, Mitri G, Greinix HT. Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv. 2019 Jul 23;3(14):2218-2229. doi: 10.1182/bloodadvances.2019000145.

ipd_sharing: No

lead_sponsor: Mallinckrodt

location_country:
Spain
Italy
Austria
United Kingdom
Hungary
United States
France
Germany

location_facility: Universita de Genova - Ospedale S. Martino

location_facility: University of Birmingham: Queen Elizabeth Hospital

location_facility: General Hospital of Vienna (Medical University of Vienna)

location_facility: Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,

location_facility: Medical City Dallas Hospital,Transplant center

location_facility: Methodist healthcare system of san Antonio

location_facility: Indiana Blood and Marrow Transplantation Research

location_facility: Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,


primary_purpose: Prevention

title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Spain
United Kingdom
Australia
Sweden
United States
France
Mexico
Germany

location_facility: Children'S Hospital At Westmead; Department of Nephrology

location_facility: University of Florida Pediatric Nephrology

location_facility: Royal Hospital For Sick Children; Dept. of Child Health

location_facility: Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

location_facility: Uni of Utah Health Science Center; Pediatric Nephrology

location_facility: Hop Necker Enfants Malades;Nephrologie Pediatrique

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: UCLA Center For Health Sciences; Division of Pediatric Nephrology

location_facility: KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover

location_facility: Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

summary: This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.


type: Other Identifier

title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

summary: This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

ReferenceCitation: Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE 3rd, Mariathasan S, O'Hear C, Narayanan S, Fassò M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. Clin Cancer Res. 2021 Jun 15;27(12):3360-3369. doi: 10.1158/1078-0432.CCR-20-1981. Epub 2021 Feb 10.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fasso M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clin Lung Cancer. 2020 Sep;21(5):455-463.e4. doi: 10.1016/j.cllc.2020.05.008. Epub 2020 May 12.

ReferenceCitation: Molinero L, Li Y, Chang CW, Maund S, Berg M, Harrison J, Fassò M, O'Hear C, Hegde P, Emens LA. Tumor immune microenvironment and genomic evolution in a patient with metastatic triple negative breast cancer and a complete response to atezolizumab. J Immunother Cancer. 2019 Oct 23;7(1):274. doi: 10.1186/s40425-019-0740-8.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Hamid O, Molinero L, Bolen CR, Sosman JA, Muñoz-Couselo E, Kluger HM, McDermott DF, Powderly JD, Sarkar I, Ballinger M, Fassò M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clin Cancer Res. 2019 Oct 15;25(20):6061-6072. doi: 10.1158/1078-0432.CCR-18-3488. Epub 2019 Jul 29.

ReferenceCitation: Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fassò M, O'Hear C, Lin YG, Emens LA. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol. 2019 Aug;154(2):314-322. doi: 10.1016/j.ygyno.2019.05.021. Epub 2019 Jun 14.

ReferenceCitation: Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fassò M, Molinero L, Schmid P. Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study. JAMA Oncol. 2019 Jan 1;5(1):74-82. doi: 10.1001/jamaoncol.2018.4224.

ReferenceCitation: Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fassò M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.

ReferenceCitation: Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fassò M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. Eur J Cancer. 2018 Sep;101:201-209. doi: 10.1016/j.ejca.2018.06.031. Epub 2018 Aug 1.

ReferenceCitation: Lukas RV, Rodon J, Becker K, Wong ET, Shih K, Touat M, Fassò M, Osborne S, Molinero L, O'Hear C, Grossman W, Baehring J. Clinical activity and safety of atezolizumab in patients with recurrent glioblastoma. J Neurooncol. 2018 Nov;140(2):317-328. doi: 10.1007/s11060-018-2955-9. Epub 2018 Aug 2.

ReferenceCitation: Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fassò M, O'Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncol. 2018 Apr 1;4(4):537-544. doi: 10.1001/jamaoncol.2017.5440.

ReferenceCitation: McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fassò M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11.

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

lead_sponsor: Genentech, Inc.

location_country:
United Kingdom
United States
Spain
France

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Stanford Univ Medical Center; Dept Central Pharmacy

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr


title: An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

summary: This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

study_type: Observational

time_perspective: Retrospective

location_country:
Brazil
Spain
Italy
Australia
Netherlands
Canada
Czech Republic
United States
France
Belgium
Norway
Germany


title: A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

summary: The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

ReferenceCitation: Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

lead_sponsor: CSL Behring

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Mexico
Netherlands
Argentina
Canada
Hungary
Korea, Republic of
United States
France
South Africa
Belgium
Japan
Germany
Czechia

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc

location_facility: Centre De Recherche Musculo-Squelettique


title: A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

acronym: SAKURA

summary: The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

lead_sponsor: Santen Inc.

location_country:
Poland
Brazil
Spain
Italy
Austria
United Kingdom
Argentina
United States
Chile
France
India
Colombia
Israel
Germany
Peru
Turkey
Japan


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

acronym: MEASURE 1

summary: This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

ReferenceCitation: Braun J, Buehring B, Baraliakos X, Gensler LS, Porter B, Quebe-Fehling E, Haemmerle S. Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1. BMC Musculoskelet Disord. 2021 Dec 13;22(1):1037. doi: 10.1186/s12891-021-04930-1.

ReferenceCitation: van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

ReferenceCitation: Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Østergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.

ReferenceCitation: Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.

ReferenceCitation: Himmler S, Branner JC, Ostwald DA. The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab. J Comp Eff Res. 2021 Feb;10(2):143-155. doi: 10.2217/cer-2020-0077. Epub 2020 Nov 30.

ReferenceCitation: Kvien TK, Conaghan PG, Gossec L, Strand V, Østergaard M, Poddubnyy D, Williams N, Porter B, Shete A, Gilloteau I, Deodhar A. Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials. Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.

ReferenceCitation: Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

ReferenceCitation: Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

ReferenceCitation: Braun J, Deodhar A, Landewé R, Baraliakos X, Miceli-Richard C, Sieper J, Quebe-Fehling E, Martin R, Porter B, Gandhi KK, van der Heijde D; MEASURE 1 and MEASURE 2 study groups. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018 Nov 21;4(2):e000749. doi: 10.1136/rmdopen-2018-000749. eCollection 2018.

ReferenceCitation: Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B. Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies. Int J Rheum Dis. 2017 May;20(5):589-596. doi: 10.1111/1756-185X.13094. Epub 2017 May 25. Erratum in: Int J Rheum Dis. 2017 Jul;20(7):911.

ReferenceCitation: Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards HB; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077. doi: 10.1136/annrheumdis-2016-209730. Epub 2016 Dec 13.

ReferenceCitation: Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.

ReferenceCitation: Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
United Kingdom
Italy
Russian Federation
Mexico
Netherlands
Canada
United States
France
Peru
Turkey
Belgium
Germany
Bulgaria


title: Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (ThoraflexTM)in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

summary:
ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy.

Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane.

The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced.

The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.

status: Withdrawn

lead_sponsor: Vascutek Ltd.

location_country:
United Kingdom
Italy
Netherlands
Canada
France
Belgium
Germany

location_facility: Academic Medical Centre (AMC), Department of Surgery

location_facility: Erasmus Medical Centre, Department of Surgery

location_facility: Cliniques Universitaires Saint-Luc (UCL)

location_facility: Medisch Specturm Twente, Department of Surgery

location_facility: Institute University de Cardiologie et de

location_facility: University of Maastricht, Department of Surgery

location_facility: Service de Chirurgie Cardaque et Vasculaire

intervention_type: Device


title: A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

acronym: STRASS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Bonvalot S, Gronchi A, Le Péchoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honoré C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litière S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

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

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Maria Sklodowska-Curie Memorial Cancer Center

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

intervention_type: Radiation


acronym: Safety FU Study of Amb in 8-17yr olds

title: An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired

location_country:
Spain
Italy
Russian Federation
Argentina
Hungary
United States
France
Japan
Germany

summary:
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met:

the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons).

The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.


title: A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years

summary: A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.


title: A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus

summary: To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

ReferenceCitation: Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J. Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.

ReferenceCitation: Rockstroh JK, Soriano V, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA. Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011. Erratum in: HIV Clin Trials. 2015 Nov;16(6):236-8.

lead_sponsor: ViiV Healthcare

location_country:
Poland
Spain
United Kingdom
Hungary
Puerto Rico
United States
France
Germany
Czechia

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: Kaiser Permanente Sunnybrook Medical Office

location_facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

location_facility: University of Iowa Hospitals and Clinics

location_facility: Southwest Infectious Disease Clinical Research Inc.

location_facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

location_facility: University of California, San Francisco - Mt. Zion Hospital

location_facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

location_facility: Alameda Health System - Highland Hospital

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: Centre Hospitalier Cochin Saint Vincent de Paul

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust

location_facility: Community AIDS Resource Inc dba Care Resource

location_facility: University of South Florida Health - HIV Clinical Research Unit

location_facility: University of Puerto Rico - School of Medicine

location_facility: Hospital Reina Sofia Hospital Provincial

location_facility: Egyesített Szent István és Szent László Kórház Rendelőintézet

location_facility: The Office of Dr. Franco Antonio Felizarta, M.D.


title: A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

summary: This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.

ReferenceCitation: Schuler M, Berardi R, Lim WT, de Jonge M, Bauer TM, Azaro A, Gottfried M, Han JY, Lee DH, Wollner M, Hong DS, Vogel A, Delmonte A, Akimov M, Ghebremariam S, Cui X, Nwana N, Giovannini M, Kim TM. Molecular correlates of response to capmatinib in advanced non-small-cell lung cancer: clinical and biomarker results from a phase I trial. Ann Oncol. 2020 Jun;31(6):789-797. doi: 10.1016/j.annonc.2020.03.293. Epub 2020 Mar 30.

ReferenceCitation: Bang YJ, Su WC, Schuler M, Nam DH, Lim WT, Bauer TM, Azaro A, Poon RTP, Hong D, Lin CC, Akimov M, Ghebremariam S, Zhao S, Giovannini M, Ma B. Phase 1 study of capmatinib in MET-positive solid tumor patients: Dose escalation and expansion of selected cohorts. Cancer Sci. 2020 Feb;111(2):536-547. doi: 10.1111/cas.14254. Epub 2019 Dec 30.

location_country:
Taiwan
Hong Kong
Spain
Italy
Australia
Netherlands
Canada
Thailand
Korea, Republic of
United States
France
Israel
Singapore
Norway
Germany

location_facility: Sarah Cannon Research Institute Dept of Onc

location_facility: Karmanos Cancer Institute Wayne St Karmanos

location_facility: University of Texas/MD Anderson Cancer Center Dept of Onc


title: A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-polycythemia Veramyelofibrosis (PPV-MF) or Post-essentialthrombocythemia-myelofibrosis (PET-MF) and Baseline Platelet Counts ≥50 x109/L and <100 x109/L (EXPAND)

summary: This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L

ReferenceCitation: Guglielmelli P, Kiladjian JJ, Vannucchi AM, Duan M, Meng H, Pan L, He G, Verstovsek S, Boyer F, Barraco F, Niederwieser D, Pungolino E, Liberati AM, Harrison C, Roussou P, Wroclawska M, Karumanchi D, Sinclair K, Te Boekhorst PAW, Gisslinger H. Efficacy and safety of ruxolitinib in patients with myelofibrosis and low platelet count (50 × 10(9)/L to <100 × 10(9)/L) at baseline: the final analysis of EXPAND. Ther Adv Hematol. 2022 Sep 10;13:20406207221118429. doi: 10.1177/20406207221118429. eCollection 2022.

lead_sponsor: Incyte Corporation

location_country:
United Kingdom
Italy
Austria
Netherlands
United States
France
China
Germany


title: A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: Comprehensive Clinical Development, Inc.

location_facility: The Center For Pharmaceutical Research. Pc


title: A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: FOCUS

summary: This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with multiple myeloma who have received all available approved treatment options and may therefore be considered candidates for palliative care.

ReferenceCitation: Hájek R, Masszi T, Petrucci MT, Palumbo A, Rosiñol L, Nagler A, Yong KL, Oriol A, Minarik J, Pour L, Dimopoulos MA, Maisnar V, Rossi D, Kasparu H, Van Droogenbroeck J, Yehuda DB, Hardan I, Jenner M, Calbecka M, Dávid M, de la Rubia J, Drach J, Gasztonyi Z, Górnik S, Leleu X, Munder M, Offidani M, Zojer N, Rajangam K, Chang YL, San-Miguel JF, Ludwig H. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). Leukemia. 2017 Jan;31(1):107-114. doi: 10.1038/leu.2016.176. Epub 2016 Jun 24.

ReferenceCitation: Hájek R, Bryce R, Ro S, Klencke B, Ludwig H. Design and rationale of FOCUS (PX-171-011): a randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM). BMC Cancer. 2012 Sep 19;12:415. doi: 10.1186/1471-2407-12-415.

lead_sponsor: Amgen

location_country:
Poland
Serbia
Spain
Greece
Austria
Australia
Italy
New Zealand
Russian Federation
United Kingdom
Sweden
Hungary
Korea, Republic of
France
Israel
Belgium
Germany
Slovakia
Czechia


title: Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.

acronym: DESSOLVE-II

summary: The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.

ReferenceCitation: Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W; DESSOLVE II Investigators. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study. Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.

ReferenceCitation: Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J; DESSOLVE II Investigators. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention. 2015 Apr;10(12):1383-90. doi: 10.4244/EIJY14M05_03.

lead_sponsor: Micell Technologies

location_country:
United Kingdom
New Zealand
Sweden
France
Belgium
Netherlands

location_facility:
Papworth Hospital
UMC Utrecht
St. Antonius Ziekenhuis
Royal Sussex Hosp
Mercy Angiography Unit
University Hospital South Manchester
Auckland City Hospital
OLV
TweeSteden Ziekenhuis
Christchurch Hospital
Clinique Pasteur
Dunedin Hospital
Claude Galien Hospital
KUL Cardiology Gasthuisberg
Virga Jesse Ziekenhuis
Norfolk/Norwich UHosp
Brussels University Hospital
Jacques Cartier Hospital
Orebro University Hospital
Ziekenhuis Oost-Limburg
Hospital Weezenlanden
Royal Brompton
Cardiovascular Center
Antwerp Hospital, ZNA Middelheim
Guy's & St. Thomas'
Sahlgrenska University Hospital
Wellington Hospital
Southampton UHT


acronym: ASTERIA II

title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

ReferenceCitation: Ferrer M, Giménez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul - Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12. Erratum in: J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1810.

ReferenceCitation: Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003. Review.

ReferenceCitation: Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosén K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. Erratum in: J Invest Dermatol. 2019 Feb;139(2):496-497.

ReferenceCitation: Gimenéz-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosén K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016.

ReferenceCitation: Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosén KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14.

ReferenceCitation: Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenéz-Arnau A, Kaplan AP, Rosén K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.

ReferenceCitation: Maurer M, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24. Erratum in: N Engl J Med. 2013 Jun 13;368(24):2340-1.

location_country:
Denmark
Poland
Spain
Italy
United States
France
Turkey
Germany

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.


title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

acronym: ANDANTE

summary: This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

ReferenceCitation: Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

ReferenceCitation: Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

lead_sponsor: Pfizer

location_country:
Denmark
Brazil
Romania
United Kingdom
Greece
Ireland
Australia
Italy
Canada
Czech Republic
New Zealand
Switzerland
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai

location_facility: Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group

location_facility: Institut klinicke a experimentalni mediciny

location_facility: University of Louisville Research Foundation

location_facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

location_facility: Physicians Endoscopy Center (Colonoscopy)

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Houston Hospital for Specialized Surgery (Endoscopy Only)

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: The University of Texas Health Science Center at Houston

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Pioneer Research Solutions, Inc. (Admin. Office)

location_facility: Research Protocol Management Specialists

location_facility: London Health Science Centre - University Hospital

location_facility: The Institute Of Gastroenterology & Liver Diseases

location_facility: Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital

location_facility: An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw

location_facility: Royal Free Hospital (Royal Free London NHS Foundation Trust)

location_facility: Weill Cornell Imaging at New York Presbyterian Hospital

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Maryland Diagnostics & Therapeutic Endo Center

location_facility: The University of Texas Medical School at Houston

location_facility: Klinicke centrum ISCARE I.V.F. - gastroenterologie

location_facility: University Of Louisville Healthcare Outpatient Center

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: University of California San Francisco at Mount Zion

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

location_facility: Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika

location_facility: The University of Chicago Medical Center (Ucmc)

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Hopital Saint-Antoine - Service De Gastroenterologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: VCU Medical Investigational Drug Service (IDS)

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Hospital Universitário Fraga Filho da UFRJ

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Medicinsk Afdeling, Gastroenterologisk Sektion

location_facility: Addenbrooke's Hospital, Department of Gastroenterology

location_facility: International Clinical Research - US, LLC

location_facility: University of California - San Francisco

location_facility: A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and

location_facility: Azienda Ospedaliera - Universita di Padova

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

location_facility: Colonoscopy and X-rays: OU Physicians Building

location_facility: Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Weill Cornell Medical College of Cornell University-Greenberg

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

location_facility: Medical Research Center of Connecticut, LLC


acronym: ASTERIA I

title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

ReferenceCitation: Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosén K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Jan;135(1):67-75. doi: 10.1038/jid.2014.306. Epub 2014 Jul 21. Erratum in: J Invest Dermatol. 2015 Mar;135(3):925.

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.


title: An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients With Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

summary: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.

ReferenceCitation: Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23.

location_country:
Netherlands
United States
Italy
France


title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

ReferenceCitation: Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.

ReferenceCitation: Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.

ReferenceCitation: Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting β(2)-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.

ReferenceCitation: Bateman ED, Djukanović R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.

ReferenceCitation: Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.

ReferenceCitation: Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.

ReferenceCitation: Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum in: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Taiwan
Brazil
Romania
Greece
Russian Federation
Argentina
Canada
Ukraine
Korea, Republic of
United States
France
Peru
Mexico
Germany
Slovakia

location_facility:
Teva Investigational Site 227
Teva Investigational Site 341
Teva Investigational Site 763
Teva Investigational Site 47
Teva Investigational Site 44
Teva Investigational Site 556
Teva Investigational Site 364
Teva Investigational Site 207
Teva Investigational Site 365
Teva Investigational Site 25
Teva Investigational Site 629
Teva Investigational Site 380
Teva Investigational Site 764
Teva Investigational Site 382
Teva Investigational Site 105
Teva Investigational Site 624
Teva Investigational Site 628
Teva Investigational Site 229
Teva Investigational Site 543
Teva Investigational Site 362
Teva Investigational Site 626
Teva Investigational Site 360
Teva Investigational Site 143
Teva Investigational Site 221
Teva Investigational Site 69
Teva Investigational Site 621
Teva Investigational Site 142
Teva Investigational Site 630
Teva Investigational Site 203
Teva Investigational Site 625
Teva Investigational Site 372
Teva Investigational Site 363
Teva Investigational Site 369
Teva Investigational Site 554
Teva Investigational Site 563
Teva Investigational Site 150
Teva Investigational Site 366
Teva Investigational Site 632
Teva Investigational Site 681
Teva Investigational Site 540
Teva Investigational Site 544
Teva Investigational Site 123
Teva Investigational Site 223
Teva Investigational Site 144
Teva Investigational Site 635
Teva Investigational Site 222
Teva Investigational Site 523
Teva Investigational Site 225
Teva Investigational Site 67
Teva Investigational Site 685
Teva Investigational Site 41
Teva Investigational Site 140
Teva Investigational Site 633
Teva Investigational Site 226
Teva Investigational Site 631
Teva Investigational Site 623
Teva Investigational Site 557
Teva Investigational Site 367
Teva Investigational Site 521
Teva Investigational Site 27
Teva Investigational Site 559
Teva Investigational Site 45
Teva Investigational Site 57
Teva Investigational Site 760
Teva Investigational Site 343
Teva Investigational Site 524
Teva Investigational Site 209
Teva Investigational Site 46
Teva Investigational Site 202
Teva Investigational Site 53
Teva Investigational Site 204
Teva Investigational Site 541
Teva Investigational Site 145
Teva Investigational Site 371
Teva Investigational Site 59
Teva Investigational Site 28
Teva Investigational Site 765
Teva Investigational Site 520
Teva Investigational Site 562
Teva Investigational Site 622
Teva Investigational Site 680
Teva Investigational Site 761
Teva Investigational Site 522
Teva Investigational Site 104
Teva Investigational Site 686
Teva Investigational Site 368
Teva Investigational Site 560
Teva Investigational Site 126
Teva Investigational Site 683
Teva Investigational Site 381
Teva Investigational Site 682
Teva Investigational Site 342
Teva Investigational Site 220
Teva Investigational Site 121
Teva Investigational Site 361
Teva Investigational Site 48
Teva Investigational Site 370
Teva Investigational Site 40
Teva Investigational Site 102
Teva Investigational Site 558
Teva Investigational Site 561
Teva Investigational Site 620
Teva Investigational Site 120
Teva Investigational Site 205


title: A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis

summary: This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

ReferenceCitation: Reinisch W, Panés J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.

location_country:
Poland
Spain
Austria
Netherlands
Canada
Hungary
United States
France
Romania
Germany
Bulgaria

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Centre

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly

location_facility: MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie

location_facility: The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii

location_facility: Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

location_facility: Centennial Medical Center Tower Medical Imaging

location_facility: DKTs Sveta Anna, Gastroenterologichen cabinet

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Centennial Medical Center Physicians Park

location_facility: University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Gastroenterology Research of San Antonio

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Columbia Medical Group - The First Clinic Inc.

location_facility: MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia


title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations

acronym: LYNX

summary: This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

time_perspective: Prospective

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Denmark
Belgium
Portugal
Spain
Greece
Italy
United Kingdom
Sweden
France
Peru
Colombia
Germany
Slovakia
Czechia

location_facility: Universitair Ziekenhuis Leuven - Campus Sint-Raphaël

location_facility: AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem

location_facility: Birmingham and Midland Eye Centre, Consultant Ophthalmologist

location_facility: Istituto Giannina Gaslini, Divisione di Oculistica

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Detska Fakultna nemocnica s poliklinikou Bratislava

location_facility: Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie

location_facility: Universitaetsklinikum Giessen und Marburg


acronym: BRITE

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures

lead_sponsor: UCB Pharma

ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

ReferenceCitation: Ben-Menachem E, Mameniškienė R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained ≥50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum in: Epilepsy Res. 2017 Nov;137:165-166.

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.

ReferenceCitation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3:CD011501. doi: 10.1002/14651858.CD011501.pub3. Review.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Toledo M, Brandt C, Quarato PP, Schulz AL, Cleveland JM, Wagener G, Klein P. Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial. Epilepsy Behav. 2021 May;118:107897. doi: 10.1016/j.yebeh.2021.107897. Epub 2021 Mar 27.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Russian Federation
Puerto Rico
India
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Latvia
Estonia
Finland
Korea, Republic of
France
Netherlands

summary: This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.


title: A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

lead_sponsor: Shire

ReferenceCitation: Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

location_country:
Poland
Spain
Ireland
Austria
Italy
United Kingdom
Canada
Ukraine
Sweden
United States
France
Romania
Germany

location_facility: JPM Van Stralen Medicine Professional Corp.

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot

location_facility: Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Praxis Dr. Friedrich Kaiser un Ingrid Marinesse

location_facility: Horsham Child and Adolescent Mental Health Services

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Centre HospitalierUniversitaire d'Amiens, Hoptial Nord

location_facility: Municipal Institution "Institute of healthcare for children and adolescences NAMNU

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: James Paget University Hospital NHS Trust

location_facility: Klinikum der Johannes-Guttenberg-Universitat Mainz

location_facility: Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital

location_facility: Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa

location_facility: Department of Child and Adolescent Psychiatry

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"

location_facility: IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva

location_facility: Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde

location_facility: Rochester Center for Behavioral Medicine

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept

location_facility: Psychiatric Centers at San Diego, Feighner Research

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski

location_facility: O.F. Maltsev Poltava Regional Psychiatric Hospital

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

location_facility: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine

location_facility: University of Nebraska Medical Center, Dept. of Psychiatry

location_facility: Institut fur Ganzheitiche Medzin und Wissenschaft GmbH

location_facility: Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes

location_facility: Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Spitalul Clinic de Urgenta Pentru Copii Cluj

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Instituto Valenciano de Neurología Pediatrica

summary: For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).


title: A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

summary: The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

ReferenceCitation: Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.

location_country:
United Kingdom
Australia
Canada
Czech Republic
United States
France
Belgium
Germany

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Krajska nemocnice Liberec a.s., Plicni oddeleni

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Synexus, Merseyside Clinical Research Centre

location_facility: Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire

location_facility: Synexus Scotland Clinical Research Centre

location_facility: The Center for Pharmaceutical Research, PC

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: CHU Côte de Nacre, Unité de Coordination de Tabacologie

location_facility: Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie

location_facility: Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Ronald Reagan University of California Los Angeles Medical Center

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Mestska nemocnice Ostrava, Plicni oddeleni

location_facility: University of California Los Angeles David Geffen School of Medicine


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

acronym: ESTEEM 2

summary: This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

ReferenceType: background

ReferenceCitation: Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.

location_country:
Denmark
Spain
Italy
Austria
Canada
Switzerland
United States
France
Germany

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

location_facility: A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Arizona Skin and Laser Therapy Inst., Ltd.

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Northwestern University Northwestern Medical Faculty Foundation

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Centre d'lnvestigation Clinique, Hopital Jean Minjoz

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

location_facility: Hospital Universitario Fundacion Alcorcon


title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies

summary: This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

status: Active, not recruiting

ReferenceCitation: Smyth LM, Reichel JB, Tang J, Patel JAA, Meng F, Selcuklu DS, Houck-Loomis B, You D, Samoila A, Schiavon G, Li BT, Razavi P, Piscuoglio S, Reis-Filho JS, Taylor BS, Baselga J, Solit DB, Hyman DM, Berger MF, Chandarlapaty S. Utility of Serial cfDNA NGS for Prospective Genomic Analysis of Patients on a Phase I Basket Study. JCO Precis Oncol. 2021 Jan 8;5. pii: PO.20.00184. doi: 10.1200/PO.20.00184. eCollection 2021.

ReferenceCitation: Smyth LM, Batist G, Meric-Bernstam F, Kabos P, Spanggaard I, Lluch A, Jhaveri K, Varga A, Wong A, Schram AM, Ambrose H, Carr TH, de Bruin EC, Salinas-Souza C, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Nikolaou M, Schiavon G, Razavi P, Banerji U, Baselga J, Hyman DM, Chandarlapaty S. Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer. NPJ Breast Cancer. 2021 Apr 16;7(1):44. doi: 10.1038/s41523-021-00251-7.

ReferenceCitation: Smyth LM, Tamura K, Oliveira M, Ciruelos EM, Mayer IA, Sablin MP, Biganzoli L, Ambrose HJ, Ashton J, Barnicle A, Cashell DD, Corcoran C, de Bruin EC, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Pass M, Rowlands V, Schiavon G, Banerji U, Scaltriti M, Taylor BS, Chandarlapaty S, Baselga J, Hyman DM. Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with AKT1 (E17K)-Mutant, ER-Positive Metastatic Breast Cancer. Clin Cancer Res. 2020 Aug 1;26(15):3947-3957. doi: 10.1158/1078-0432.CCR-19-3953. Epub 2020 Apr 20.

ReferenceCitation: Banerji U, Dean EJ, Pérez-Fidalgo JA, Batist G, Bedard PL, You B, Westin SN, Kabos P, Garrett MD, Tall M, Ambrose H, Barrett JC, Carr TH, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Elvin P, Foxley A, Lawrence P, Lindemann JPO, Maudsley R, Pass M, Rowlands V, Rugman P, Schiavon G, Yates J, Schellens JHM. A Phase I Open-Label Study to Identify a Dosing Regimen of the Pan-AKT Inhibitor AZD5363 for Evaluation in Solid Tumors and in PIK3CA-Mutated Breast and Gynecologic Cancers. Clin Cancer Res. 2018 May 1;24(9):2050-2059. doi: 10.1158/1078-0432.CCR-17-2260. Epub 2017 Oct 24.

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
United States
France
Singapore
Japan
Netherlands

status_simplified: Ongoing


title: Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)

acronym: AUTONOMY

summary: Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Croatia
Poland
Brazil
Romania
Austria
Russian Federation
Argentina
Canada
Lithuania
Puerto Rico
United States
France
South Africa
Mexico

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: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

summary: The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

ReferenceCitation: Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmelé T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.

ReferenceCitation: Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmelé T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.

ReferenceCitation: McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.

ReferenceCitation: Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.

ReferenceCitation: Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.

lead_sponsor: Astute Medical, Inc.

location_country:
Spain
United Kingdom
Austria
Canada
Sweden
United States
France
Germany

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Beth Israel Deaconess Med. Center (BIDMC)

location_facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: University of Chicago Medical Center Section of Nephrology


title: CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome

acronym: CHI SQUARE

summary: Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

ReferenceCitation: Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89.

ReferenceCitation: Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8.

ReferenceCitation: Spieker LE, Sudano I, Hürlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Lüscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402.

ReferenceCitation: Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4.

ReferenceCitation: Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.

ReferenceCitation: Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2.

ReferenceCitation: Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067.

ReferenceCitation: Tardif JC, Grégoire J, L'Allier PL, Ibrahim R, Lespérance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodés-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. Epub 2007 Mar 26.

ReferenceCitation: Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300.

ReferenceCitation: Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC, Kastelein JJ, Keyserling C, Klepp H, Koenig W, L'Allier PL, Lespérance J, Lüscher TF, Paolini JF, Tawakol A, Waters DD; Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014 Dec 7;35(46):3277-86. doi: 10.1093/eurheartj/ehu171. Epub 2014 Apr 29.

lead_sponsor: Cerenis Therapeutics, SA

location_country:
Netherlands
United States
Canada
France

location_facility: Detroit Medical Center (DMC) Cardiovascular Institute

location_facility: Cardiac and Vascular Research Center of Northern Michigan

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)

location_facility: Centre Hospitalier Universitaire de Toulouse Rangueil

location_facility: Montreal General Hospital Research Institute

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: MultiCare Health System Research Institute / Cardiac Study Center

location_facility: Centre Hospitalier Régional de Trois-Rivières

location_facility: University of North Carolina Medical Center

location_facility: Centre de Santé et de Services Sociaux de Laval

location_facility: Jacksonville Center for Clinical Research

location_facility: Buffalo Cardiology & Pulmonary Associates

location_facility: Palm Beach Heart Institute, LLC - Zasa Clinical Research