title: GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

acronym: PEARL

summary:
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.

Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.

After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.

There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.

As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

location_country:
Poland
United Kingdom
Russian Federation
Estonia
Korea, Republic of
United States
France
Japan
Germany


status: Completed

primary_purpose: Treatment

intervention_type: Biological

title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

study_completion_date_type: Actual

lead_sponsor: Allergan

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Actual

location_country:
Poland
Italy
Canada
France
United States
Turkey
Belgium
Czechia

location_facility: Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Washington University School of Medicine

location_facility: CHU de Limoges - Hopital Mere et l'Enfant

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: William Beaumont Hospital Research Institute

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

summary: This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.

lead_sponsor_type: industriel

status_simplified: Completed


title: Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

acronym: DASFREE

summary: The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

primary_purpose: Other

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
Canada
United States
France
Germany

location_facility:
Local Institution - 0022
Local Institution - 0012
Local Institution - 0027
Local Institution - 0011
Local Institution - 0005
Local Institution - 0029
Local Institution - 0010
Local Institution - 0021
Local Institution - 0015
Local Institution - 0025
Local Institution - 0003
Local Institution - 0018
Local Institution - 0030
Local Institution - 0026
Local Institution - 0024
Local Institution - 0016
Local Institution - 0023
Local Institution - 0028
Local Institution - 0001
Local Institution - 0020
Local Institution - 0019
Local Institution - 0013
Local Institution - 0002
Local Institution - 0014
Local Institution - 0009
Local Institution - 0008
Local Institution - 0006
Local Institution - 0017

intervention_type: Drug


intervention_type: Other

title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Latvia
Australia
Netherlands
Canada
Czech Republic
Russian Federation
Switzerland
United Kingdom
Hungary
Korea, Republic of
France
Israel
Singapore
Turkey
Belgium
Germany
Slovakia

summary: To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).


ipd_sharing: Yes

acronym: DIALOG

title: A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Patterson B, Samis J, Aimone P, Allepuz A, Titorenko K, Sosothikul D. A phase 2 study of nilotinib in pediatric patients with CML: long-term update on growth retardation and safety. Blood Adv. 2021 Jul 27;5(14):2925-2934. doi: 10.1182/bloodadvances.2020003759.

ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Aimone P, Allepuz A, Quenet S, Hourcade-Potelleret F, Hertle S, Sosothikul D. Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Blood. 2019 Dec 5;134(23):2036-2045. doi: 10.1182/blood.2019000069.

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

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

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Thailand
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Malaysia

location_facility: University of Texas Southwestern Medical Center Oncology

location_facility: Lucile Salter Packard Children's Hospital at Stanford

summary: To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).


ipd_sharing: No

acronym: ACT DMD

title: A Phase 3 Efficacy and Safety Study of Ataluren in Patients With Nonsense Mutation Dystrophinopathy

lead_sponsor: PTC Therapeutics

ReferenceCitation: Shieh PB, Elfring G, Trifillis P, Santos C, Peltz SW, Parsons JA, Apkon S, Darras BT, Campbell C, McDonald CM; Members of the Ataluren Phase IIb Study Group; Members of the Ataluren Phase IIb Study Clinical Evaluator Training Group; Members of the ACT DMD Study Group; Members of the ACT DMD Clinical Evaluator Training Group. Meta-analyses of deflazacort versus prednisone/prednisolone in patients with nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2021 Dec;10(18):1337-1347. doi: 10.2217/cer-2021-0018. Epub 2021 Oct 25.

ReferenceCitation: McDonald CM, Wei LJ, Flanigan KM, Elfring G, Trifillis P, Muntoni F; ACT DMD Clinical Evaluator Training Group; ACT DMD Study Group. Evaluating longitudinal therapy effects via the North Star Ambulatory Assessment. Muscle Nerve. 2021 Nov;64(5):614-619. doi: 10.1002/mus.27396. Epub 2021 Sep 2.

ReferenceCitation: Campbell C, Barohn RJ, Bertini E, Chabrol B, Comi GP, Darras BT, Finkel RS, Flanigan KM, Goemans N, Iannaccone ST, Jones KJ, Kirschner J, Mah JK, Mathews KD, McDonald CM, Mercuri E, Nevo Y, Péréon Y, Renfroe JB, Ryan MM, Sampson JB, Schara U, Sejersen T, Selby K, Tulinius M, Vílchez JJ, Voit T, Wei LJ, Wong BL, Elfring G, Souza M, McIntosh J, Trifillis P, Peltz SW, Muntoni F; PTC124-GD-007-DMD Study Group; ACT DMD Study Group; Clinical Evaluator Training Groups. Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2020 Oct;9(14):973-984. doi: 10.2217/cer-2020-0095. Epub 2020 Aug 27.

ReferenceCitation: McDonald CM, Campbell C, Torricelli RE, Finkel RS, Flanigan KM, Goemans N, Heydemann P, Kaminska A, Kirschner J, Muntoni F, Osorio AN, Schara U, Sejersen T, Shieh PB, Sweeney HL, Topaloglu H, Tulinius M, Vilchez JJ, Voit T, Wong B, Elfring G, Kroger H, Luo X, McIntosh J, Ong T, Riebling P, Souza M, Spiegel RJ, Peltz SW, Mercuri E; Clinical Evaluator Training Group; ACT DMD Study Group. Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Sep 23;390(10101):1489-1498. doi: 10.1016/S0140-6736(17)31611-2. Epub 2017 Jul 17.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
Sweden
Korea, Republic of
United States
Chile
France
Israel
Belgium
Turkey
Germany
Czechia

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: Child Neurology Center of Northwest Florida

location_facility: Seattle Children's Hospital - Childhood Cancer and Blood Disorders

location_facility: Columbia University College of Physicians & Surgeons

location_facility: University College London Institute of Child Health

location_facility: Universidade Federal do Rio de Janeiro - Instituto de Puericultura e Pediatria Martagao Gesteira

location_facility: Fondazione IRCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: University Hospital Medical Center Freiburg

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

summary: Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.


title: A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Poland
Brazil
Spain
Italy
Austria
Mexico
Netherlands
France
United States
Israel
Turkey
Belgium
Japan
Germany

location_facility: Pronto Socorro Cardiologico de Pernambuco-PROCAPE

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Hopital Haut Leveque - Group hospitalier Sud

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Okinawa Prefectural Nanbu Medical Center & Children's Med Ct

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Children's Heathcare of Atlanta, Inc. at Egleston

location_facility: Shizuoka Prefectural Children's Hospital

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico I.R.C.C.S.

location_facility: Hacettepe University Faculty of Medicine

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: National Center For Child Health And Development

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

summary: The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary:
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .

ReferenceType: background

ReferenceCitation: Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.

ReferenceCitation: Gulley JL, Rajan A, Spigel DR, Iannotti N, Chandler J, Wong DJL, Leach J, Edenfield WJ, Wang D, Grote HJ, Heydebreck AV, Chin K, Cuillerot JM, Kelly K. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):599-610. doi: 10.1016/S1470-2045(17)30240-1. Epub 2017 Mar 31.

ReferenceCitation: Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marté JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017 May;18(5):587-598. doi: 10.1016/S1470-2045(17)30239-5. Epub 2017 Mar 31.

ReferenceCitation: Guigay J, Lee KW, Patel MR, Daste A, Wong DJ, Goel S, Gordon MS, Gutierrez M, Balmanoukian A, Le Tourneau C, Mita A, Vansteene D, Keilholz U, Schöffski P, Grote HJ, Zhou D, Bajars M, Penel N. Avelumab for platinum-ineligible/refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2021 Oct;9(10). pii: e002998. doi: 10.1136/jitc-2021-002998.

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2). pii: e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Verschraegen CF, Jerusalem G, McClay EF, Iannotti N, Redfern CH, Bennouna J, Chen FL, Kelly K, Mehnert J, Morris JC, Taylor M, Spigel D, Wang D, Grote HJ, Zhou D, Munshi N, Bajars M, Gulley JL. Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study. J Immunother Cancer. 2020 Sep;8(2). pii: e001064. doi: 10.1136/jitc-2020-001064.

ReferenceCitation: Del Rivero J, Donahue RN, Marté JL, Gramza AW, Bilusic M, Rauckhorst M, Cordes L, Merino MJ, Dahut WL, Schlom J, Gulley JL, Madan RA. A Case Report of Sequential Use of a Yeast-CEA Therapeutic Cancer Vaccine and Anti-PD-L1 Inhibitor in Metastatic Medullary Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Aug 7;11:490. doi: 10.3389/fendo.2020.00490. eCollection 2020.

ReferenceCitation: Vaishampayan U, Schöffski P, Ravaud A, Borel C, Peguero J, Chaves J, Morris JC, Kotecki N, Smakal M, Zhou D, Guenther S, Bajars M, Gulley JL. Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Oct 24;7(1):275. doi: 10.1186/s40425-019-0746-2.

ReferenceCitation: Rajan A, Heery CR, Thomas A, Mammen AL, Perry S, O'Sullivan Coyne G, Guha U, Berman A, Szabo E, Madan RA, Ballester LY, Pittaluga S, Donahue RN, Tsai YT, Lepone LM, Chin K, Ginty F, Sood A, Hewitt SM, Schlom J, Hassan R, Gulley JL. Efficacy and tolerability of anti-programmed death-ligand 1 (PD-L1) antibody (Avelumab) treatment in advanced thymoma. J Immunother Cancer. 2019 Oct 21;7(1):269. doi: 10.1186/s40425-019-0723-9.

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

ReferenceCitation: Chung HC, Arkenau HT, Lee J, Rha SY, Oh DY, Wyrwicz L, Kang YK, Lee KW, Infante JR, Lee SS, Kemeny M, Keilholz U, Melichar B, Mita A, Plummer R, Smith D, Gelb AB, Xiong H, Hong J, Chand V, Safran H. Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Feb 4;7(1):30. doi: 10.1186/s40425-019-0508-1.

ReferenceCitation: Disis ML, Taylor MH, Kelly K, Beck JT, Gordon M, Moore KM, Patel MR, Chaves J, Park H, Mita AC, Hamilton EP, Annunziata CM, Grote HJ, von Heydebreck A, Grewal J, Chand V, Gulley JL. Efficacy and Safety of Avelumab for Patients With Recurrent or Refractory Ovarian Cancer: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):393-401. doi: 10.1001/jamaoncol.2018.6258.

ReferenceCitation: Keilholz U, Mehnert JM, Bauer S, Bourgeois H, Patel MR, Gravenor D, Nemunaitis JJ, Taylor MH, Wyrwicz L, Lee KW, Kasturi V, Chin K, von Heydebreck A, Gulley JL. Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Jan 16;7(1):12. doi: 10.1186/s40425-018-0459-y.

ReferenceCitation: Hassan R, Thomas A, Nemunaitis JJ, Patel MR, Bennouna J, Chen FL, Delord JP, Dowlati A, Kochuparambil ST, Taylor MH, Powderly JD, Vaishampayan UN, Verschraegen C, Grote HJ, von Heydebreck A, Chin K, Gulley JL. Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):351-357. doi: 10.1001/jamaoncol.2018.5428.

ReferenceCitation: Le Tourneau C, Hoimes C, Zarwan C, Wong DJ, Bauer S, Claus R, Wermke M, Hariharan S, von Heydebreck A, Kasturi V, Chand V, Gulley JL. Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial. J Immunother Cancer. 2018 Oct 22;6(1):111. doi: 10.1186/s40425-018-0424-9.

ReferenceCitation: Patel MR, Ellerton J, Infante JR, Agrawal M, Gordon M, Aljumaily R, Britten CD, Dirix L, Lee KW, Taylor M, Schöffski P, Wang D, Ravaud A, Gelb AB, Xiong J, Rosen G, Gulley JL, Apolo AB. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5. Erratum in: Lancet Oncol. 2018 Jul;19(7):e335.

ReferenceCitation: Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, Heery CR, Gulley JL, Schlom J. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer. 2017 Feb 21;5:20. doi: 10.1186/s40425-017-0220-y. eCollection 2017.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Poland
Taiwan
United Kingdom
Korea, Republic of
France
United States
Belgium
Germany
Czechia

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie - Dept of Digestive System Oncology

location_facility: Georgetown University Medical Center- Research Parent

location_facility: University of North Carolina at Chapel Hill

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center

location_facility: University Hospitals Case Medical Center - Case Comprehensive Cancer Center

location_facility: Columbia University College of Phys & Surgeons

location_facility: University of California Davis Health System

location_facility: Centre Paul Strauss - Service de Médecine Oncologique

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

location_facility: Kansas City Research Institute, LLC - Phase I Unit

location_facility: Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology

location_facility: Scripps Health dba Scripps Clinical Research Services

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.

location_facility: Augusta University - formerly Georgia Regents University

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: Derriford Hospital - Dept of Oncology Clinical Trials

location_facility: Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH - Innere Medizin II Haematologie / Onkologie

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Peachtree Hematology-Oncology Consultants, PC

location_facility: Nemocnice Rudolfa a Stefanie Benesov, a.s.

location_facility: Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: California Cancer Associates for Research & Excellence, Inc

location_facility: Seoul National University Bundang Hospital

location_facility: OSU - James Comprehensive Cancer Center - Division of Hematology


acronym: RESPIRE 1

title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.

lead_sponsor: Bayer

ReferenceCitation: De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1). pii: 1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.

ReferenceCitation: Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.

location_country:
Denmark
Spain
Italy
Latvia
Australia
New Zealand
Argentina
United Kingdom
United States
France
Israel
Japan
Germany
Slovakia

summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.


title: BEL114674: A 2 Year Study of Efficacy and Safety of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

summary: The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.

status: Withdrawn

study_completion_date_type: Anticipated

ReferenceCitation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11:CD004293. doi: 10.1002/14651858.CD004293.pub4. Review.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Czech Republic
United States
France
Germany

status_simplified: Unknown


title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

acronym: MAESTRO

summary: Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

ReferenceCitation: Gatzoulis MA, Landzberg M, Beghetti M, Berger RM, Efficace M, Gesang S, He J, Papadakis K, Pulido T, Galiè N; MAESTRO Study Investigators. Evaluation of Macitentan in Patients With Eisenmenger Syndrome. Circulation. 2019 Jan 2;139(1):51-63. doi: 10.1161/CIRCULATIONAHA.118.033575.

lead_sponsor: Actelion

location_country:
Serbia
Spain
United Kingdom
United States
Romania
Philippines
Poland
Portugal
Austria
Russian Federation
Israel
Turkey
Mexico
Malaysia
China
Germany
Bulgaria
Greece
Vietnam
France
Chile

location_facility: Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm

location_facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Bristol Univ Hosp Congenital Heart Centre

location_facility: Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Hosp La Timone - Dept Pediatric Cardiology

location_facility: Instituto Nacional de Cardiologia (Inc) Ignacio Chavez

location_facility: Hosp Pompidou - Dept Congenital Cardiac Diseases

location_facility: Unidad de Investigacion Clin En Med, Sc (Udicem)

location_facility: Sci Institute Systemic Problems Cardio Diseases Kemerovo

location_facility: Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii

location_facility: The General Hosp of Shenyang Military Region

location_facility: Guangdong General Hospital, Cardiology Dpt

location_facility: Barnes-Jewish Hosp/Wash Univ School of Med

location_facility: Hosp Cardiology Haut Leveque - Dept Congenital Diseases

location_facility: Emory University Hospital/the Emory Clinic

location_facility: Mother and Child Health Care Inst "Dr Vukan Cupic"

location_facility: Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept

location_facility: Texas Children'S Hosp - Dept of Cardiology

location_facility: Universitätsklinikum Giessen - Pediatric Heart Center

location_facility: Hosp Univ Virgen Macarena - Dpt Cardiology

location_facility: Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto


title: Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

acronym: MAESTRO-OL

summary: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

status: Terminated

location_country:
Poland
Portugal
Romania
Serbia
Greece
Austria
Mexico
Russian Federation
Spain
United Kingdom
Vietnam
United States
Chile
China
France
Malaysia
Philippines
Germany
Bulgaria

location_facility: Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm

location_facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Bristol Univ Hosp Congenital Heart Centre

location_facility: Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Sci Institute Systemic Poriblems Cardio Diseases Kemerovo

location_facility: Hosp La Timone - Dept Pediatric Cardiology

location_facility: Mother and Child Health Care Institute Dr. Vukan Cupic


title: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

acronym: SABLE

summary: The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

location_country:
Portugal
Spain
Italy
Austria
Argentina
Canada
Sweden
United States
France
Israel
Belgium
Germany
Slovakia

status_simplified: Ongoing


title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

summary: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

ReferenceCitation: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9. Erratum in: Lancet Oncol. 2018 Nov;19(11):e581.

lead_sponsor: Kyowa Kirin, Inc.

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Netherlands
Switzerland
United States
France
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Boston Medical Center, Department of Medicine, Section of Hem/Onc

location_facility: University of Rochester School of Medicine

location_facility: The Christie Hospital Foundation NHS Trust

location_facility: The Winship Cancer Institute (Emory University)

location_facility: University of Pittsburgh School of Medicine

location_facility: Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna


title: A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

location_country:
United Kingdom
Italy
United States
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Argentina
India
Israel
Panama
Turkey
Mexico
Singapore
Slovakia
Canada
Guatemala
Hungary
Germany
Finland
Korea, Republic of
France

summary: This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.


title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

summary: This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

ReferenceCitation: Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4). doi: 10.15326/jcopdf.6.4.2019.0131.

location_country:
Slovenia
Guatemala
Hungary
United States
France
Panama
Colombia
Slovakia
Egypt


title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

lead_sponsor: Takeda

type: Registry Identifier

ReferenceCitation: Ansell SM, Radford J, Connors JM, Długosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM, Smolewski P, Savage KJ, Bartlett NL, Eom HS, Abramson JS, Dong C, Campana F, Fenton K, Puhlmann M, Straus DJ; ECHELON-1 Study Group. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2022 Jul 28;387(4):310-320. doi: 10.1056/NEJMoa2206125. Epub 2022 Jul 13.

ReferenceCitation: Evens AM, Connors JM, Younes A, Ansell SM, Kim WS, Radford J, Feldman T, Tuscano J, Savage KJ, Oki Y, Grigg A, Pocock C, Dlugosz-Danecka M, Fenton K, Forero-Torres A, Liu R, Jolin H, Gautam A, Gallamini A. Older patients (aged ≥60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. Haematologica. 2022 May 1;107(5):1086-1094. doi: 10.3324/haematol.2021.278438.

ReferenceCitation: Straus DJ, Długosz-Danecka M, Connors JM, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2. Erratum in: Lancet Haematol. 2022 Feb;9(2):e91.

ReferenceCitation: Straus DJ, Długosz-Danecka M, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Connors JM, Radford J, Munoz J, Kim WS, Advani R, Ansell SM, Younes A, Miao H, Liu R, Fenton K, Forero-Torres A, Gallamini A. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020 Mar 5;135(10):735-742. doi: 10.1182/blood.2019003127.

ReferenceCitation: Ramchandren R, Advani RH, Ansell SM, Bartlett NL, Chen R, Connors JM, Feldman T, Forero-Torres A, Friedberg JW, Gopal AK, Gordon LI, Kuruvilla J, Savage KJ, Younes A, Engley G, Manley TJ, Fenton K, Straus DJ. Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clin Cancer Res. 2019 Mar 15;25(6):1718-1726. doi: 10.1158/1078-0432.CCR-18-2435. Epub 2019 Jan 7.

ReferenceCitation: Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984. Epub 2017 Dec 10. Erratum in: N Engl J Med. 2018 Mar 1;378(9):878.

ReferenceCitation: Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

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

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Turkey
Norway
Brazil
Canada
Hungary
Denmark
Taiwan
Korea, Republic of
France

summary: This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)


title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

acronym: ATLAS

summary: This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

ReferenceCitation: Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018 Jun 10;6(1):14. doi: 10.1186/s40345-018-0122-z.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Taiwan
Canada
Hungary
Korea, Republic of
United States
France
Romania
Japan
Malaysia


title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

summary: The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Canada
Switzerland
United States
France
Germany


acronym: WAVES

title: A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

lead_sponsor: Gilead Sciences

ReferenceType: result

ReferenceCitation: Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.

ReferenceCitation: Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.

ReferenceCitation: Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.

ReferenceCitation: Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

ReferenceCitation: Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

location_country:
Portugal
United Kingdom
Italy
Dominican Republic
Mexico
Russian Federation
Thailand
Uganda
Puerto Rico
United States
France
Belgium

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

location_facility: GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: University of California, Davis Medical Center

location_facility: Queen Elizabeth Hospital, South London Healthcare NHS Trust

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

location_facility: GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: Clinica Malattie Infettive, Azienda Ospedaliero Universitaria

location_facility: George Washington University Medical Faculty Associates

location_facility: Mortimer Market Centre and Central and North West London NHS Foundation Trust

location_facility: Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central

location_facility: Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: East Carolina University The Brody School of Medicine Div. of Infectious Diseases

location_facility: Wexner Medical Center at the Ohio State University

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: Hospital de Santa Maria - Serviço de Doenças Infecciosas

location_facility: Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare

location_facility: St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: Instituto Dominicano de Estudio Virologicos - IDEV

location_facility: Salvador B Gautier Hospital, Infectious Diseases Department

location_facility: Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Temple University Hospital- Internal General Medicine

location_facility: Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"

location_facility: Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases

location_facility: Federal State Budgetary Institution "Republic Clinical Infectious Hospital"

location_facility: Department of Health Sciences - University of Milan - San Paolo Hospital

location_facility: GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)

location_facility: State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: Bamrasnaradura lnfectious Disease Institute

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases

summary: The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.


title: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma

ReferenceCitation: Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.

location_country:
Denmark
Spain
United Kingdom
Mexico
United States
France
Belgium
Germany

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: University Of Pittsburgh Medical Center Cancer Center

location_facility: James Whitcomb Riley Hospital For Children

location_facility: H. Lee Moffitt Cancer Center & Research Institute

summary: The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab


title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

ReferenceCitation: Coates LC, Smolen JS, Mease PJ, Husni ME, Merola JF, Lespessailles E, Kishimoto M, Macpherson L, Bradley AJ, Bolce R, Helliwell PS. Comparative performance of composite measures from two phase III clinical trials of ixekizumab in psoriatic arthritis. RMD Open. 2022 Sep;8(2). pii: e002457. doi: 10.1136/rmdopen-2022-002457.

ReferenceCitation: Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

ReferenceCitation: Schweikert B, Malmberg C, Núñez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

ReferenceCitation: Chandran V, van der Heijde D, Fleischmann RM, Lespessailles E, Helliwell PS, Kameda H, Burgos-Vargas R, Erickson JS, Rathmann SS, Sprabery AT, Birt JA, Shuler CL, Gallo G. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020 Oct 1;59(10):2774-2784. doi: 10.1093/rheumatology/kez684.

ReferenceCitation: Combe B, Rahman P, Kameda H, Cañete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaçi D, Birt J, Lee CH, Shuler CL, Lin CY, Gladman DD. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

ReferenceCitation: Coates LC, Kishimoto M, Gottlieb A, Shuler CL, Lin CY, Lee CH, Mease PJ. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567. eCollection 2017.

ReferenceCitation: van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, Shuler CL, Carlier H, Benichou O, Mease PJ. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1). J Rheumatol. 2018 Mar;45(3):367-377. doi: 10.3899/jrheum.170429. Epub 2017 Dec 15. Erratum in: J Rheumatol. 2018 Nov;45(11):1608.

ReferenceCitation: Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

location_country:
Poland
Spain
United Kingdom
Russian Federation
Estonia
Mexico
Canada
Ukraine
United States
France
Belgium
Japan
Netherlands
Bulgaria
Czechia

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: MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial

summary: This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

ReferenceCitation: Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.

location_country:
Poland
United Kingdom
Russian Federation
Australia
Argentina
Canada
Ukraine
Korea, Republic of
United States
Chile
France
Romania
Germany


title: A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma

acronym: TAURUS

summary: Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

lead_sponsor: AVEO Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium
Germany


title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects With Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

acronym: NASH

summary:
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

Randomized Double-Blind Phase
Open-Label Phase (optional)

ReferenceCitation: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.

ReferenceCitation: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.

ReferenceCitation: Bosch J, Harrison S, Ratziu V, Shiffman M, Diehl A, Caldwell S, et al. Impact of modest weight reduction on liver histology, portal pressure, and clinical events in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2017; 66 (1): S159-S160.

ReferenceCitation: Sanyal A, Goodman Z, Harrison S, Rockey DC, Diehl AM, Caldwell S, et al. Correlation between the hepatic venous pressure gradient and alpha-smooth muscle actin (SMA) expression in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2016; 64 (2): S251.

ReferenceCitation: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.

ReferenceCitation: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.

ReferenceCitation: Bosch J, Ratziu V, Rockey DC, Ghalib RH, Thuluvath PJ, Shiefke I, et al. Correlation between noninvasive markers of fibrosis and the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 578A.

ReferenceCitation: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.

ReferenceCitation: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.

ReferenceCitation: Sanyal AJ, Goodman ZD, Abdelmalek MF, Harrison SA, Rockey DC, Diehl AM, et al. Clinical and histologic correlates of the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 577A.

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

ReferenceCitation: Harrison SA, Abdelmalek MF, Caldwell S, Shiffman ML, Diehl AM, Ghalib R, Lawitz EJ, Rockey DC, Schall RA, Jia C, McColgan BJ, McHutchison JG, Subramanian GM, Myers RP, Younossi Z, Ratziu V, Muir AJ, Afdhal NH, Goodman Z, Bosch J, Sanyal AJ; GS-US-321-0105 and GS-US-321-0106 Investigators. Simtuzumab Is Ineffective for Patients With Bridging Fibrosis or Compensated Cirrhosis Caused by Nonalcoholic Steatohepatitis. Gastroenterology. 2018 Oct;155(4):1140-1153. doi: 10.1053/j.gastro.2018.07.006. Epub 2018 Jul 7.

location_country:
Spain
Italy
United Kingdom
Canada
Puerto Rico
United States
France
Germany

location_facility: University of California, San Diego (UCSD)

location_facility: University of California San Francisco (UCSF)

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Walter Reed National Military Medical Center

location_facility: Indiana University School of Medicine, Division of Gastroenterology/Hepatology

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of Mississippi Medical Center

location_facility: University Hospitals Case Medical Center


title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

summary:
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH.

It will consist of 2 phases:

Randomized Double-Blind Phase
Open-Label Phase (optional)

ReferenceCitation: Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.

publications_result: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.

location_country:
Spain
Italy
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Virginia Commonwealth University Health System

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Miami Veterans Administration Healthcare System

location_facility: King's College Hospital NHS Foundation Trust No. 1 Account

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Nottingham University Hospitals Queens Medica


title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis

acronym: BREVAS

summary: The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

ReferenceCitation: Jayne D, Blockmans D, Luqmani R, Moiseev S, Ji B, Green Y, Hall L, Roth D, Henderson RB, Merkel PA; BREVAS Study Collaborators. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. Arthritis Rheumatol. 2019 Jun;71(6):952-963. doi: 10.1002/art.40802. Epub 2019 Apr 16.

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Poland
Romania
Spain
Ireland
Italy
Australia
Mexico
Canada
Russian Federation
Switzerland
United Kingdom
Sweden
Hungary
United States
France
Peru
Belgium
Norway
Germany
Czechia


title: A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee

summary: In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

lead_sponsor: Tetec AG

location_country:
Poland
United Kingdom
Latvia
Austria
Lithuania
Switzerland
Hungary
France
Germany
Czechia

location_facility: CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie

location_facility: Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie

location_facility: Hospital of Traumatology and Orthopaedics, Trauma Department

location_facility: Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego

location_facility: Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej

location_facility: NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice

location_facility: Szpital sw. Lukasza BGL Sp z o.o. S.K.A.

location_facility: B-A-Z Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Fakultni nemocnice Hradec Kralove - Ortopedicka klinika

location_facility: Orthopädische Klinik und Poliklinik der LMU München

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie

location_facility: JSC "SK Impeks Medicinos Diagnostikos Centras"

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Fakultni nemocnice Brno - Ortopedicka klinika

location_facility: Urazova nemocnice v Brne - Traumatologie

intervention_type: Procedure


title: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer

summary: This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5.

lead_sponsor: Genentech, Inc.

location_country:
Romania
Spain
Italy
United Kingdom
Australia
New Zealand
United States
France
Belgium
Germany


title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
To evaluate the effect of alirocumab on other lipid parameters
To evaluate the safety and tolerability of alirocumab

ReferenceCitation: Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.

ReferenceCitation: Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16.

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

lead_sponsor: Sanofi

location_country:
Denmark
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
South Africa

location_facility:
Investigational Site Number 710918
Investigational Site Number 208903
Investigational Site Number 840962
Investigational Site Number 643908
Investigational Site Number 840986
Investigational Site Number 410913
Investigational Site Number 840917
Investigational Site Number 840997
Investigational Site Number 124914
Investigational Site Number 208908
Investigational Site Number 840952
Investigational Site Number 410926
Investigational Site Number 840998
Investigational Site Number 410922
Investigational Site Number 643922
Investigational Site Number 410927
Investigational Site Number 376908
Investigational Site Number 410905
Investigational Site Number 710904
Investigational Site Number 710914
Investigational Site Number 710905
Investigational Site Number 840971
Investigational Site Number 840982
Investigational Site Number 376903
Investigational Site Number 840944
Investigational Site Number 840914
Investigational Site Number 410908
Investigational Site Number 208905
Investigational Site Number 208911
Investigational Site Number 840301
Investigational Site Number 840987
Investigational Site Number 410921
Investigational Site Number 643921
Investigational Site Number 840931
Investigational Site Number 840966
Investigational Site Number 840939
Investigational Site Number 124902
Investigational Site Number 840933
Investigational Site Number 840940
Investigational Site Number 840976
Investigational Site Number 840946
Investigational Site Number 643903
Investigational Site Number 643911
Investigational Site Number 410901
Investigational Site Number 643931
Investigational Site Number 840991
Investigational Site Number 710917
Investigational Site Number 348906
Investigational Site Number 840979
Investigational Site Number 124918
Investigational Site Number 804902
Investigational Site Number 410920
Investigational Site Number 840906
Investigational Site Number 376907
Investigational Site Number 840963
Investigational Site Number 410915
Investigational Site Number 208914
Investigational Site Number 840964
Investigational Site Number 840945
Investigational Site Number 643927
Investigational Site Number 250907
Investigational Site Number 840928
Investigational Site Number 376906
Investigational Site Number 840302
Investigational Site Number 643932
Investigational Site Number 410909
Investigational Site Number 840959
Investigational Site Number 643929
Investigational Site Number 840303
Investigational Site Number 348905
Investigational Site Number 643928
Investigational Site Number 840943
Investigational Site Number 208906
Investigational Site Number 643914
Investigational Site Number 840932
Investigational Site Number 643924
Investigational Site Number 840920
Investigational Site Number 840974
Investigational Site Number 840984
Investigational Site Number 840960
Investigational Site Number 840925
Investigational Site Number 250903
Investigational Site Number 710913
Investigational Site Number 840902
Investigational Site Number 840961
Investigational Site Number 840921
Investigational Site Number 840930
Investigational Site Number 840912
Investigational Site Number 804905
Investigational Site Number 410924
Investigational Site Number 410923
Investigational Site Number 643925
Investigational Site Number 348901
Investigational Site Number 250905
Investigational Site Number 840981
Investigational Site Number 840988
Investigational Site Number 840970
Investigational Site Number 643904
Investigational Site Number 348903
Investigational Site Number 410914
Investigational Site Number 208913
Investigational Site Number 376902
Investigational Site Number 840985
Investigational Site Number 710909
Investigational Site Number 376904
Investigational Site Number 840913
Investigational Site Number 250906
Investigational Site Number 208907
Investigational Site Number 124903
Investigational Site Number 348908
Investigational Site Number 840994
Investigational Site Number 840935
Investigational Site Number 840990
Investigational Site Number 840949
Investigational Site Number 840918
Investigational Site Number 840995
Investigational Site Number 840903
Investigational Site Number 840938
Investigational Site Number 710915
Investigational Site Number 208901
Investigational Site Number 840980
Investigational Site Number 643906
Investigational Site Number 376901
Investigational Site Number 840973
Investigational Site Number 840955
Investigational Site Number 840992


title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Mexico
Argentina
Ukraine
Hungary
United States
France
Belgium
Germany
Czechia


title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

acronym: PRINCIPAL

summary: The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

lead_sponsor: Bristol-Myers Squibb

location_country:
Taiwan
Hong Kong
United Kingdom
Greece
Italy
Australia
Mexico
Argentina
Finland
New Zealand
Russian Federation
Korea, Republic of
United States
Chile
France
Singapore
Belgium
Japan
Netherlands

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases


title: A 12-week Treatment, Randomized, Blinded, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of NVA237 (50 µg o.d.) Compared to Tiotropium (18 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

ReferenceCitation: Chapman KR, Beeh KM, Beier J, Bateman ED, D'Urzo A, Nutbrown R, Henley M, Chen H, Overend T, D'Andrea P. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014 Jan 17;14:4. doi: 10.1186/1471-2466-14-4.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Croatia
Poland
Taiwan
Latvia
Estonia
Canada
Czech Republic
Lithuania
Guatemala
Korea, Republic of
France
India
South Africa
Philippines
Germany


title: Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group

summary:
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.

The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

enrollment_type: Anticipated

ReferenceCitation: Wildiers H, Tryfonidis K, Dal Lago L, Vuylsteke P, Curigliano G, Waters S, Brouwers B, Altintas S, Touati N, Cardoso F, Brain E. Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer (EORTC 75111-10114): an open-label, randomised, phase 2 trial from the Elderly Task Force/Breast Cancer Group. Lancet Oncol. 2018 Mar;19(3):323-336. doi: 10.1016/S1470-2045(18)30083-4. Epub 2018 Feb 9.

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

location_country:
Poland
Portugal
United Kingdom
Italy
Sweden
France
Belgium
Netherlands

location_facility: Velindre NHS Trust - Velindre Cancer Centre

location_facility: Peterborough and Stamford Hospitals NHS Foundation Trust - Peterborough City Hospita

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Uppsala University Hospital - Akademiska Sjukhuset


title: International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

acronym: IGOS

summary:
International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

ReferenceCitation: Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Péréon Y, Bürmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutiérrez-Gutiérrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barré Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.

ReferenceCitation: Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

ipd_sharing: Undecided

lead_sponsor: Erasmus Medical Center

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Australia
Argentina
Puerto Rico
Malaysia
Canada
Bangladesh
Switzerland
China
Germany
Denmark
Taiwan
Greece
France
Netherlands

location_facility: The affiliated Hospital of Xuzhou Medical University

location_facility: National Hospital of Neurology and Neurosurgery

location_facility: Concord Repatriation General Hospital Sydney

location_facility: Southern Illinois University School of Medicine

location_facility: The university of Texas Health Science Center

location_facility: University of Maryland School of Medicine

location_facility: Wexner Medical Center at The Ohio State University

location_facility: University of Vermont College of Medicine

location_facility: Affiliated Hospital of Jining Medical University

location_facility: Hospital Universitario Central de Asturias


acronym: PROTECT-VIII

title: A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

lead_sponsor: Bayer

ReferenceCitation: Baumann A, Piel I, Hucke F, Sandmann S, Hetzel T, Schwarz T. Pharmacokinetics, excretion, distribution, and metabolism of 60-kDa polyethylene glycol used in BAY 94-9027 in rats and its value for human prediction. Eur J Pharm Sci. 2019 Mar 15;130:11-20. doi: 10.1016/j.ejps.2019.01.015. Epub 2019 Jan 14.

ReferenceCitation: Lalezari S, Reding MT, Pabinger I, Holme PA, Negrier C, Chalasani P, Shin HJ, Wang M, Tseneklidou-Stoeter D, Maas Enriquez M. BAY 94-9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results. Haemophilia. 2019 Nov;25(6):1011-1019. doi: 10.1111/hae.13853. Epub 2019 Oct 17.

ReferenceCitation: Reding MT, Ng HJ, Poulsen LH, Eyster ME, Pabinger I, Shin HJ, Walsch R, Lederman M, Wang M, Hardtke M, Michaels LA. Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017 Mar;15(3):411-419. doi: 10.1111/jth.13597. Epub 2017 Feb 22.

location_country:
Denmark
Poland
Taiwan
Belgium
Romania
United Kingdom
Italy
Austria
Netherlands
Canada
Korea, Republic of
United States
France
Israel
Norway
Colombia
Japan
Germany
Singapore
Turkey

summary:
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.

The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.

In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.

120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.

Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms

summary: The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

ReferenceCitation: Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.

lead_sponsor: Amgen

location_country:
Poland
United Kingdom
Czech Republic
United States
France
Malaysia


title: A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

summary: This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
United States
Italy
United Kingdom
France

location_facility: Vanderbilt University, Vanderbilt Ingram Cancer Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Medical University of South Carolina, Hollings Cancer Center

location_facility: Tufts University School of Medicine-Tufts Medical Center

location_facility: Universitaria Policlinico S. Orsola Malpighi, Institute of Hemtology "L. & A. Seragnoli"

location_facility: UT Southwestern Medical Center, Simmons Cancer Center


title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

acronym: FEATURE

summary: The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. Epub 2016 Aug 30.

location_country:
Estonia
Canada
United States
France
Germany


title: Patient Retrospective Outcomes (PRO)

acronym: PRO

summary: This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

status: Recruiting

time_perspective: Retrospective

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Switzerland
Sweden
Puerto Rico
United States
France
Germany

location_facility: Pres. Osp. Civile Santi Antonio e Biagio

location_facility: Twin Cities Pain Clinic & Surgery Center

location_facility: Vidant Roanoke - Chowan Hospital Pain Center

location_facility: Advanced Interventional Pain Management and Research Clinic, Inc.

location_facility: Multidisciplinary Pain Management Services

location_facility: UCSD Medical Center - Jacobs Medical Center

location_facility: Interventional Pain Specialists of Wisconsin

location_facility: West Florida Orthopedics and Spine Surgery

location_facility: Basildon and Thurrock University Hospitals NHS

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Integrative Pain and Wellness Associates

location_facility: Womens Health and Research Institute of Australia

location_facility: Willis-Knighton River Cities Clinical Research Center

location_facility: Western Reserve Spine and Pain Institute

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Advanced Diagnostic Pain Treatment Centers

intervention_type: Device