title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

ReferenceCitation: Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28.

location_country:
Poland
Spain
Italy
Russian Federation
United States
France
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hematology and Oncology Associates at BridgePoint

location_facility: Universitätsklinikum der Friedrich-Schiller-Universität Jena

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Hospital Clinico Universitario de Valencia

location_facility: New York University Clinical Cancer Center

location_facility: Ludwig-Maximilians-Universität München Klinikum Großhadern

location_facility: Nizhny Novgorod City Oncology Dispensary

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

location_facility: University of California San Diego Medical Center

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.

location_facility: Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: Klinikum Region Hannover GmbH, Krankenhaus Siloah

location_facility: TORI Network (Translational Oncology Research Intl)

location_facility: State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Cancer Research Center n.a. Blokhin, Chemotherapy Dept.

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Suburban Hematology Oncology Associates, PC

location_facility: Providence Saint Joseph Medical Center-Disney Family Cancer Center

location_facility: Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie

location_facility: Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik" sp. z o. o.

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Krankenanstalt Mutterhaus der Borromäerinnen e.V.

location_facility: Comprehensive Hematology Oncology Centers, Inc.

location_facility: Hôpital Trousseau - Service de Gastroenterologie


type: EudraCT Number

title: A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

summary: The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Côté P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Southern California Permanente Medical Group

location_facility: University Of Puerto Rico School Of Medicine

location_facility: University Of North Carolina At Chapel Hill

location_facility: Upper Delaware Valley Infectious Diseases, Pc

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

summary: The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

design_allocation: Non-Randomized

location_country:
Germany
United States
Spain
France

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

location_facility: Penn State Milton S. Hershey Medical Center


title: LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

summary: This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

study_start_date_type: Actual

design_allocation: Randomized

ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Märten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

ReferenceCitation: Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kölbeck K, Fan J, Dodd N, Märten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.

ReferenceCitation: Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kölbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Hong Kong
Spain
Ireland
United Kingdom
Australia
Canada
Sweden
Korea, Republic of
France
Singapore
China
Norway
Germany

location_facility: Haematology & Oncology Clinics of Australasia (HOCA)

location_facility: British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer

location_facility: Hospital Regional Universitario de Málaga

location_facility: The Affiliated Cancer Hospital, Guangxi Medical University

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: CTR Oncologie du Pays Basque, Onco, Bayonne

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: The First Hospital of Chinese Medical University

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Cross Cancer Institute (University of Alberta)


title: A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

ReferenceCitation: Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.

ReferenceCitation: Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Spain
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

location_facility:
Site Reference ID/Investigator# 57543
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Site Reference ID/Investigator# 55539
Site Reference ID/Investigator# 44610
Site Reference ID/Investigator# 44755
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Site Reference ID/Investigator# 55538


title: A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL

summary: The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

lead_sponsor: MedImmune LLC

location_country:
Poland
Spain
Russian Federation
Canada
Hungary
United States
France
Israel
Turkey
Germany
Czechia

intervention_type: Procedure


title: A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

summary: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

ReferenceCitation: Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schöffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. doi: 10.1016/S1470-2045(17)30381-9. Epub 2017 Jun 23. Erratum in: Lancet Oncol. 2018 Feb;19(2):e78.

ReferenceCitation: Chawla SP, Cranmer LD, Van Tine BA, Reed DR, Okuno SH, Butrynski JE, Adkins DR, Hendifar AE, Kroll S, Ganjoo KN. Phase II study of the safety and antitumor activity of the hypoxia-activated prodrug TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. J Clin Oncol. 2014 Oct 10;32(29):3299-306. doi: 10.1200/JCO.2013.54.3660. Epub 2014 Sep 2.

lead_sponsor: Threshold Pharmaceuticals

location_country:
Denmark
Poland
Spain
Italy
Austria
Russian Federation
Canada
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly

location_facility: Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem

location_facility: University Hospitals Seidman Cancer Center

location_facility: Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco

location_facility: Carolinas Hematology-oncology Associates-Blumenthal Cancer Center

location_facility: FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology

location_facility: Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology

location_facility: Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont

location_facility: University Hospital Herlev at Copenhagen

location_facility: Winship Cancer Institute of Emory University, Midtown Campus

location_facility: ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia

location_facility: GUZ "Regional Oncology Dispensay", Kazan

location_facility: Virginia Commonwealth Universtiy-Massey Cancer Center

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej-Curie

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation

location_facility: Fondazione del Piemonte per l'Oncologia, Instituto per la Ricerca e la Cura del cancro (I.R.C.C.), Dipartimento Oncologico, Direzione Operativa Oncologia Medica a Direzione Universitaria

location_facility: South Florida Center for Gynecologic Oncology

location_facility: University of Iowa Health Care - University of Iowa Hospital

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm

location_facility: Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1

location_facility: Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg

location_facility: Mayo Clinic-Florida-Cancer Clinical Studies Unit

location_facility: Hospital Sant Joan de Deu, Department de Oncologia

location_facility: H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica

location_facility: Wake Forest University Baptist Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital

location_facility: BCCA- Vancouver Cancer Centre - Division of Medical Oncology

location_facility: Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck

location_facility: Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center

location_facility: IRCCS Centro di Riferimento Oncologico-Struttura Operativa

location_facility: H.Lee Moffitt Cancer Center and Research Institute

location_facility: The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine

location_facility: Kootenai Health - Kootenai Cancer Center


title: A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

summary: This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

ReferenceCitation: Bateman ED, Guerreros AG, Brockhaus F, Holzhauer B, Pethe A, Kay RA, Townley RG. Fevipiprant, an oral prostaglandin DP(2) receptor (CRTh2) antagonist, in allergic asthma uncontrolled on low-dose inhaled corticosteroids. Eur Respir J. 2017 Aug 24;50(2). pii: 1700670. doi: 10.1183/13993003.00670-2017. Print 2017 Aug.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United Kingdom
Italy
United States
Peru
Romania
Japan
South Africa
Poland
Austria
Russian Federation
Argentina
India
Turkey
Mexico
Canada
Guatemala
Hungary
Bulgaria
Greece
France
Colombia
Netherlands


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension

acronym: ASCEND in SPMS

summary:
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

status: Terminated

ReferenceCitation: Beynon V, George IC, Elliott C, Arnold DL, Ke J, Chen H, Zhu L, Ke C, Giovannoni G, Scaramozza M, Campbell N, Bradley DP, Franchimont N, Gafson A, Belachew S. Chronic lesion activity and disability progression in secondary progressive multiple sclerosis. BMJ Neurol Open. 2022 Jun 7;4(1):e000240. doi: 10.1136/bmjno-2021-000240. eCollection 2022.

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

ReferenceCitation: Kapoor R, Ho PR, Campbell N, Chang I, Deykin A, Forrestal F, Lucas N, Yu B, Arnold DL, Freedman MS, Goldman MD, Hartung HP, Havrdová EK, Jeffery D, Miller A, Sellebjerg F, Cadavid D, Mikol D, Steiner D; ASCEND investigators. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018 May;17(5):405-415. doi: 10.1016/S1474-4422(18)30069-3. Epub 2018 Mar 12.

lead_sponsor: Biogen

location_country:
Denmark
Poland
Spain
Ireland
Italy
Netherlands
Russian Federation
Canada
Finland
United Kingdom
Sweden
United States
France
Israel
Belgium
Germany
Czechia

status_simplified: Unknown


title: Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age

summary:
The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.

primary_purpose: Prevention

ReferenceCitation: Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.

lead_sponsor: Bayer

location_country:
United Kingdom
Australia
Finland
France
Norway
Sweden


acronym: IMUNITI

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

lead_sponsor: Janssen Research & Development, LLC

type: Other Identifier

source: euctr

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

ReferenceCitation: Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022 Mar;20(3):578-590.e4. doi: 10.1016/j.cgh.2021.02.025. Epub 2021 Feb 19.

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum in: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

ReferenceCitation: Hanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, Johanns J, Adedokun OJ, Sands BE, Rutgeerts P, de Villiers WJS, Colombel JF, Ghosh S. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. J Crohns Colitis. 2020 Jan 1;14(1):23-32. doi: 10.1093/ecco-jcc/jjz110.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Gasink C, Jacobstein D, Zou B, Johanns J, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther. 2018 Jul;48(1):65-77. doi: 10.1111/apt.14794. Epub 2018 May 24.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.

location_country:
Croatia
Serbia
Spain
United Kingdom
United States
Belgium
Iceland
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Ireland
New Zealand
Korea, Republic of
France
Netherlands

summary: The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

summary: This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

location_country:
Croatia
Serbia
Spain
United Kingdom
United States
South Africa
Belgium
Iceland
Japan
Poland
Russian Federation
Australia
Israel
Brazil
Canada
Hungary
Germany
Bulgaria
New Zealand
Korea, Republic of
France
Netherlands


title: A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

summary: This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

ReferenceCitation: Li J, Sasane M, Zhang J, Zhao J, Ricculli ML, Yao Z, Redhu S, Signorovitch J. Is time to progression associated with post-progression survival in previously treated metastatic non-small cell lung cancer with BRAF V600E mutation? A secondary analysis of phase II clinical trial data. BMJ Open. 2018 Aug 17;8(8):e021642. doi: 10.1136/bmjopen-2018-021642.

ReferenceCitation: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. doi: 10.1016/S1470-2045(17)30679-4. Epub 2017 Sep 11.

ReferenceCitation: Planchard D, Besse B, Groen HJM, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-993. doi: 10.1016/S1470-2045(16)30146-2. Epub 2016 Jun 6.

ReferenceCitation: Planchard D, Kim TM, Mazieres J, Quoix E, Riely G, Barlesi F, Souquet PJ, Smit EF, Groen HJ, Kelly RJ, Cho BC, Socinski MA, Pandite L, Nase C, Ma B, D'Amelio A Jr, Mookerjee B, Curtis CM Jr, Johnson BE. Dabrafenib in patients with BRAF(V600E)-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 May;17(5):642-50. doi: 10.1016/S1470-2045(16)00077-2. Epub 2016 Apr 11.

ipd_sharing: Yes

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:
Taiwan
Spain
Italy
United Kingdom
Netherlands
Korea, Republic of
United States
France
Norway
Japan
Germany


title: A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

acronym: VIVID-DME

summary: To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

ReferenceType: result

ReferenceCitation: Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.

ReferenceCitation: Brown DM, Schmidt-Erfurth U, Do DV, Holz FG, Boyer DS, Midena E, Heier JS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Korobelnik JF. Intravitreal Aflibercept for Diabetic Macular Edema: 100-Week Results From the VISTA and VIVID Studies. Ophthalmology. 2015 Oct;122(10):2044-52. doi: 10.1016/j.ophtha.2015.06.017. Epub 2015 Jul 18.

ReferenceCitation: Keating GM. Aflibercept: A Review of Its Use in Diabetic Macular Oedema. Drugs. 2015 Jul;75(10):1153-60. doi: 10.1007/s40265-015-0421-y. Review.

ReferenceCitation: Dhoot DS, Moini H, Reed K, Du W, Vitti R, Berliner AJ, Singh RP. Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials. Eye (Lond). 2022 Apr 19. doi: 10.1038/s41433-022-02058-7. [Epub ahead of print]

ReferenceCitation: Midena E, Gillies M, Katz TA, Metzig C, Lu C, Ogura Y. Impact of Baseline Central Retinal Thickness on Outcomes in the VIVID-DME and VISTA-DME Studies. J Ophthalmol. 2018 Mar 29;2018:3640135. doi: 10.1155/2018/3640135. eCollection 2018.

ReferenceCitation: Staurenghi G, Feltgen N, Arnold JJ, Katz TA, Metzig C, Lu C, Holz FG; VIVID-DME and VISTA-DME study investigators. Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies. Br J Ophthalmol. 2018 Jul;102(7):954-958. doi: 10.1136/bjophthalmol-2017-310664. Epub 2017 Oct 19.

ReferenceCitation: Wykoff CC, Marcus DM, Midena E, Korobelnik JF, Saroj N, Gibson A, Vitti R, Berliner AJ, Williams Liu Z, Zeitz O, Metzig C, Schmelter T, Heier JS. Intravitreal Aflibercept Injection in Eyes With Substantial Vision Loss After Laser Photocoagulation for Diabetic Macular Edema: Subanalysis of the VISTA and VIVID Randomized Clinical Trials. JAMA Ophthalmol. 2017 Feb 1;135(2):107-114. doi: 10.1001/jamaophthalmol.2016.4912.

ReferenceCitation: Ziemssen F, Schlottman PG, Lim JI, Agostini H, Lang GE, Bandello F. Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data. Int J Retina Vitreous. 2016 Jul 11;2:16. eCollection 2016.

location_country:
Denmark
Poland
Taiwan
Spain
Italy
Austria
Australia
Czech Republic
Hungary
France
Japan
Germany

intervention_type: Biological


title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Brazil
Italy
Latvia
Canada
Czech Republic
Lithuania
Thailand
Ukraine
Hungary
Korea, Republic of
United States
France
China
South Africa
Romania
Netherlands
Bulgaria
Slovakia

summary: This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.


acronym: PIX-R

title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

lead_sponsor: CTI BioPharma

ReferenceCitation: Pettengell R, Długosz-Danecka M, Andorsky D, Belada D, Georgiev P, Quick D, Singer JW, Singh SB, Pallis A, Egorov A, Salles G. Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306). Br J Haematol. 2020 Jan;188(2):240-248. doi: 10.1111/bjh.16255. Epub 2019 Dec 27.

ReferenceCitation: Belada D, Georgiev P, Dakhil S, Inhorn LF, Andorsky D, Beck JT, Quick D, Pettengell R, Daly R, Dean JP, Pavlyuk M, Failloux N, Hübel K. Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.

location_country:
Denmark
Poland
Romania
Spain
Italy
Austria
Russian Federation
United Kingdom
Ukraine
Hungary
United States
France
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"

location_facility: Cancer & Hematology Center of Western Michigan

location_facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

location_facility: Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation

location_facility: George Washington University Department of Medicine

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology

location_facility: Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

location_facility: National Cancer Institute, Department of Hematology and Transfusiology

location_facility: University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology

location_facility: University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology

location_facility: Cancer Care Specialists of Central Illinois

location_facility: State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1

location_facility: General Hospital Delta, Hematology Department

location_facility: University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: General Hospital Turnhout, Hematology Department

location_facility: Metro Minnesota Community Clinical Oncology Program

location_facility: University Hospital Martin, Department of Hematology and Transfusiology

location_facility: Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic

location_facility: Silesia Medical University, Department of Hematology and Bone Marrow Transplantation

location_facility: Siena University Hospital Authority Santa Maria alle Scotte Polyclinic

location_facility: Integrated Community Oncology Network-St. Vincent's

location_facility: Independent Public Healthcare Facility Municipal Hospital Group

location_facility: Malopolskie Medical Center S.C. , Department of Hematology

location_facility: Institut Català de Oncologia (ICO), Hospital Dr Trueta

location_facility: MHAT "Tokuda Hospital Sofia", Hematology Clinic

location_facility: University Hospital Kralovske Vinohrady, Department of Clinical Hematology

location_facility: "Ospedali Riuniti Villa Sofia-Cervello" Hospital

location_facility: Service d'hématologie clinique, Avenue Laennec Salouel

location_facility: Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense

location_facility: State Medical Institution: Republican Hospital named after V.A. Baranov

location_facility: State Healthcare Institution: Republican Clinical Oncology Center

location_facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.

location_facility: North Shore Hematology/Oncology Associates

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: Hanusch Hospital, Department of Internal Medicine III

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Green Bay Oncology-St. Mary's Hospital MC

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Hautepierre Hospital, Department of Hematology and Oncology

location_facility: University Hospital Ostrava, Institute of Clinical Hematology

location_facility: Saint Vincent Hospital Green Bay Oncology

location_facility: UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology

location_facility: J. A. Reiman University Hospital with Polyclinic in Presov

location_facility: St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care

location_facility: Oncology Center of Lublin Land, Department of Clinical Oncology

location_facility: Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology

location_facility: UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic

location_facility: Saint Quentin Hospital Center, Department of Oncology-Hematology

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Saint Luc University Hospital, Department of Hematology

location_facility: Christie Hospital, Department of Medical Oncology

location_facility: Polyclinique de Bordeaux nord Acquitaine

location_facility: Bucharest University Emergency Hospital, Hematology Clinic

location_facility: State Institution: Institute of Blood Pathology and Transfusion Medicine

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

location_facility: Institute of Hematology and Transfusion Medicine, Clinic of Hematology

location_facility: MHAT Hristo Botev, Vratsa, First Department of Internal Medicine

location_facility: Integrated Community Oncology Network-Southside

location_facility: General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology

location_facility: Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic

location_facility: Marine Hospital of Polish Red Cross, Department of Chemotheraphy

location_facility: Aalborg University Hospital, Department of Hematology

summary: The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.


title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

summary: An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Estonia
New Zealand
Korea, Republic of
France
Chile


title: A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

summary: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Estonia
New Zealand
Korea, Republic of
France
Chile
Netherlands


ipd_sharing: Undecided

title: An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

ReferenceCitation: Österborg A, Udvardy M, Zaritskey A, Andersson PO, Grosicki S, Mazur G, Kaplan P, Steurer M, Schuh A, Montillo M, Kryachok I, Middeke JM, Kulyaba Y, Rekhtman G, Gorczyca M, Daly S, Chang CN, Lisby S, Gupta I. Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2016 Sep;57(9):2037-46. doi: 10.3109/10428194.2015.1122783. Epub 2016 Jan 19.

location_country:
Poland
United Kingdom
Ireland
Austria
Italy
Russian Federation
Ukraine
Sweden
Hungary
France
Israel
Singapore
Belgium
Germany
Bulgaria
Slovakia
Czechia

summary: The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.


title: A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

ReferenceCitation: O'Dell MW, Brashear A, Jech R, Lejeune T, Marque P, Bensmail D, Ayyoub Z, Simpson DM, Volteau M, Vilain C, Picaut P, Gracies JM. Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study. PM R. 2018 Jan;10(1):1-10. doi: 10.1016/j.pmrj.2017.06.008. Epub 2017 Jun 19.

ReferenceCitation: Marciniak C, McAllister P, Walker H, Brashear A, Edgley S, Deltombe T, Khatkova S, Banach M, Gul F, Vilain C, Picaut P, Grandoulier AS, Gracies JM; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017 Dec;9(12):1181-1190. doi: 10.1016/j.pmrj.2017.06.007. Epub 2017 Jun 16.

ReferenceCitation: Gracies JM, Brashear A, Jech R, McAllister P, Banach M, Valkovic P, Walker H, Marciniak C, Deltombe T, Skoromets A, Khatkova S, Edgley S, Gul F, Catus F, De Fer BB, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Poland
Italy
Russian Federation
Hungary
France
United States
Belgium
Slovakia
Czechia

location_facility: Rancho Los Amigos National Rehabilitation Center

location_facility: Associated Neurologist of Southern CT, PT

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: National Institut for Medical Rehabilitation

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton


title: LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

summary:
The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period.

This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

ReferenceCitation: Oakes TM, Dellva MA, Waterman K, Greenbaum M, Poppe C, Goldberger C, Ahl J, Perahia DG. Edivoxetine compared to placebo as adjunctive therapy to selective serotonin reuptake inhibitors in the prevention of symptom re-emergence in major depressive disorder. Curr Med Res Opin. 2015 Jun;31(6):1179-89. doi: 10.1185/03007995.2015.1037732. Epub 2015 May 6.

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Romania
Spain
Greece
Italy
Mexico
Russian Federation
Argentina
Korea, Republic of
United States
France
Puerto Rico
Turkey
Belgium
Germany
Slovakia

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: A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

acronym: OPERA II

summary: This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

ReferenceCitation: D'Haens GR, Reinisch W, Lee SD, Tarabar D, Louis E, Kłopocka M, Klaus J, Schreiber S, Il Park D, Hébuterne X, Nagy P, Cataldi F, Martin SW, Nayak S, Banerjee A, Gorelick KJ, Sandborn WJ. Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn's Disease: The OPERA II Study. Inflamm Bowel Dis. 2022 Jul 1;28(7):1034-1044. doi: 10.1093/ibd/izab215.

lead_sponsor: Shire

location_country:
Poland
Serbia
Spain
Austria
Netherlands
Canada
Korea, Republic of
United States
France
South Africa
Norway
Belgium
Japan
Germany
Slovakia

location_facility: Washington University School of Medicine

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: "Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: University of Miami Hospital and Clinic (IP Shipment Only)

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

location_facility: University of Miami Crohn's and Colitis Center

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III


title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

summary: The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

ReferenceCitation: Heidenreich A, Chowdhury S, Klotz L, Siemens DR, Villers A, Ivanescu C, Holmstrom S, Baron B, Wang F, Lin P, Shore ND. Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur Urol. 2017 Apr;71(4):534-542. doi: 10.1016/j.eururo.2016.07.027. Epub 2016 Aug 3.

ReferenceCitation: Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung, van Os S, Hasabou N, Wang F, Bhattacharya S, Heidenreich A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016 Feb;17(2):153-163. doi: 10.1016/S1470-2045(15)00518-5. Epub 2016 Jan 14.

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Inc

location_country:
Denmark
Romania
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility:
Site GB3163
Site US62
Site FR3005
Site DE2993
Site US1527
Site CA3242
Site US2968
Site DE2989
Site DE2995
Site CA2646
Site US3025
Site FR1091
Site US1680
Site US2978
Site US2185
Site US2975
Site US2945
Site DE2992
Site BE1322
Site GB3028
Site FR442
Site CA166
Site US2935
Site FR3007
Site DE2990
Site DK1263
Site US1580
Site US2977
Site US1598
Site CA170
Site GB3029
Site BE3018
Site RO3042
Site FR3009
Site DE3287
Site GB3245
Site US44
Site US2067
Site US20
Site CA3084
Site US2027
Site US2014
Site RO3035
Site DK3354
Site RO3039
Site US892
Site GB3290
Site US1838
Site US1675
Site US81
Site US1657
Site CA2984
Site US2976
Site DE4000
Site US1934
Site CA3104
Site FR3002
Site US3078
Site US51
Site BE3015
Site DK1857
Site DE2994
Site US3182
Site US464
Site BE3289
Site US2926
Site US2934
Site US1653
Site GB3166
Site FR3003
Site US1709
Site GB2624
Site US2104
Site DE3286
Site US3630
Site GB3244
Site GB3030
Site BE3013
Site GB3355
Site GB3027
Site US3026
Site DE3270
Site GB2702
Site DK3356
Site GB1862
Site DE2988
Site BE3288
Site FR3000


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy

acronym: PROMISE

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

ReferenceCitation: Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, Horban A, Brown A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, Scott J, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014 Jun;146(7):1669-79.e3. doi: 10.1053/j.gastro.2014.02.051. Epub 2014 Mar 3.

lead_sponsor: Janssen R&D Ireland

location_country:
Poland
Spain
United Kingdom
Austria
Australia
New Zealand
Canada
Russian Federation
Puerto Rico
United States
France
Belgium
Germany


title: A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

lead_sponsor: Gilead Sciences

ReferenceCitation: Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.

ReferenceCitation: Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.

location_country:
Poland
Taiwan
Hong Kong
Portugal
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Korea, Republic of
United States
France
India
Singapore
Romania
Turkey
Germany

location_facility: Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital

location_facility: Heritage Med Research Clinic, Univ of Calgary

location_facility: Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami

location_facility: Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel

location_facility: Dharamasi Hospital,Chandni Chowk, South Shivajinagar,

location_facility: Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: Institutul National de Boli Infectioase Prof.Dr. Matei Bals

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: The Ottawa Hospital,Division of Infectious Diseases

location_facility: Pusan National University Yangsan Hospital

location_facility: Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital

location_facility: Liver Institute of Virginia, Bon Secours Health System

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Digestive Disease Cntr, Konkuk Univ Hosp

location_facility: Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: University of Alberta, Zeidler Ledcore Centre

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology

location_facility: Institute of digestive and liver disease, Dispur Hospital Ganeshguri

location_facility: LSU Gastroenterology/Center for Digestive Diseases

location_facility: Chang Gung Medical Foundation.LinKou Branch

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: Cabinet Particular Policlinic Algomed SRL-Gastroenterologie

location_facility: Advanced Liver Therapies at St. Luke's Episcopal Hospital

location_facility: University of Miami / Jackson Memorial Medical Center

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Seconda Universita degli Studi di Napoli

location_facility: All India Institute of Medical Sciences, Ansari Nagar

location_facility: Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie

location_facility: Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil

location_facility: Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza

summary:
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.


title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

acronym: OPERA

summary: Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

ReferenceCitation: Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.

ReferenceCitation: Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hébuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.

ReferenceCitation: Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ß7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.

location_country:
Poland
Serbia
Spain
Austria
Netherlands
Canada
Korea, Republic of
United States
France
South Africa
Norway
Belgium
Japan
Germany
Bulgaria
Slovakia

location_facility: Heartland Medical Research (Administrative Only)

location_facility: Washington University School of Medicine

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Consulting Radiology (Xray testing only)

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Inland Gastroenterology Medical Associates, Inc.

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.

location_facility: Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center

location_facility: Gastroenterology Specialists of Arkansas

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Minneapolis Heart Institute, West Health Campus

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej

location_facility: MBAL Sofiamed OOD,Otdelenie po gastroenterologia

location_facility: Shands Hospital at the University of Florida

location_facility: Clinical Center Nis Clinic for Gastroenterology and Hepatology

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique

location_facility: University Medical Center Groningen (UMCG)

location_facility: East side Endoscopy, LLC (for colonscopy testing only)

location_facility: Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: Connecticut Clinical Research Foundation

location_facility: Vancouver Coastal Health - Vancouver Hospital

location_facility: Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.

location_facility: The Offices of Dr. Vincent Armenio, M.D.

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Beth Israel Medical Center - Phillip Ambulatory Care Center


title: Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

lead_sponsor: Novo Nordisk A/S

ReferenceType: background

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422.

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. Epub 2016 Aug 2.

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

ReferenceCitation: Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjøth TV, Andreasen AH, Jensen CB, DeFronzo RA; NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):687-99. doi: 10.1001/jama.2015.9676. Erratum in: JAMA. 2016 Jan 5;315(1):90.

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review.

ReferenceCitation: Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4. Erratum in: Diabetes Care. 2018 Jul;41(7):1538.

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

location_country:
Taiwan
Spain
Italy
United Kingdom
Sweden
Puerto Rico
India
United States
Israel
France
South Africa
Turkey
Germany

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.


title: An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278

summary: The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

location_country:
Spain
United Kingdom
United States
Romania
Belgium
South Africa
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Sweden
Canada
China
Germany
Denmark
Taiwan
Thailand
France
Chile
Netherlands


title: A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of MP4OX Treatment, in Addition to Standard Treatment, in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Young MA, Riddez L, Kjellström BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. Epub 2004 Jan 16.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Svergun DI, Ekström F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. Epub 2007 Sep 7.

ReferenceCitation: Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. Epub 2004 Jun 18.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. Epub 2006 Jul 20.

ReferenceCitation: Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. Epub 2003 Jun 12.

ReferenceCitation: Olofsson CI, Górecki AZ, Dirksen R, Kofranek I, Majewski JA, Mazurkiewicz T, Jahoda D, Fagrell B, Keipert PE, Hardiman YJ, Levy H; Study 6084 Clinical Investigators. Evaluation of MP4OX for prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia: a randomized, double-blind, multicenter study. Anesthesiology. 2011 May;114(5):1048-63. doi: 10.1097/ALN.0b013e318215e198.

ReferenceCitation: van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Górecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.

lead_sponsor: Sangart

location_country:
Brazil
Spain
United Kingdom
Austria
Australia
New Zealand
Switzerland
France
Israel
Singapore
South Africa
Colombia
Norway
Germany

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Faculdade de Medicina de S. J. Do Rio Preto

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt a.M.

location_facility: Hospital Universitário - USP Ribeirão Preto


title: A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

ReferenceCitation: McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

location_country:
Poland
Portugal
Italy
Russian Federation
Australia
Hungary
United States
France
Belgium
Slovakia
Czechia

location_facility: Wake Forest University Baptist Medical Center

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: National Institute for Medical Rehabilitation

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Scientific Research Institute of Neurology

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"

location_facility: Associated Neurologist of Southern CT, PC

location_facility: University of North Carolina - Chapel Hill

location_facility: The University of Texas Southwestern Medical Center at Dalla


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

summary:
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.

Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

ReferenceCitation: Armstrong AJ, Anand A, Edenbrandt L, Bondesson E, Bjartell A, Widmark A, Sternberg CN, Pili R, Tuvesson H, Nordle Ö, Carducci MA, Morris MJ. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951. doi: 10.1001/jamaoncol.2018.1093.

ReferenceCitation: Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bögemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. doi: 10.1200/JCO.2016.66.9697. Epub 2016 Jun 13.

lead_sponsor: Active Biotech AB

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Romania
Poland
Russian Federation
Australia
Argentina
India
Israel
Panama
Turkey
Mexico
Sweden
Slovakia
Brazil
Lebanon
Canada
China
Germany
Bulgaria
Taiwan
Greece
Latvia
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands


title: AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY

summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Croatia
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Puerto Rico
India
Mexico
Sweden
Singapore
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Ireland
Thailand
France

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa

location_facility: Washington University School of Medicine

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Instituto Biomédico de Investigación A.C.

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: Local Laboratory Nottingham University Hospital - City Hospital Campus

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Department of Clinical Biochemistry Newcastle upon Tyne Hospitals

location_facility: Pathology Department Nottingham University Hospital - City Hospital Campus

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: Cliniques universitaires UCL de Mont-Godinne,

location_facility: 21st Century Oncology of Jacksonville, Inc.

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Department of Medical Oncology St. Bartholomew's Hospital

location_facility: Hematology-Oncology Medical Group of Fresno Inc

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz /

location_facility: UF Health Davis Cancer Pavillion and Shands Med Plaza

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Regional Treatment and Diagnostic Hematology Center Communal Establishment

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Peggy and Charles Stephenson Cancer Center (clinic location)

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: University of Kentucky A.B. Chandler Medical Center

location_facility: Moscow State Healthcare Institution City clinical hospital S.P. Botkin

location_facility: UMBAL Sveti Georgi, Klinika po hematologia

location_facility: Shands Hospital at the University of Florida

location_facility: Barbara Ann Karmanos Cancer Institute at farmington Hills

location_facility: University Hospital Dubrava Department of Internal Medicine Division of Hematology

location_facility: SBAL na Hematologichnichni Zabolyavania,CTH Sofia

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: 21st Century Oncology of Jacksonville, LLC

location_facility: Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University

location_facility: Hospital Espanol Auxilio Mutuo de Puerto Rico Inc

location_facility: OEC Record Management Company Pvt. Ltd.,

location_facility: Chemotherapy Preparative Unit St. Bartholomew's Hospital

location_facility: Disney Family Cancer Center at Providence St Joseph Medical Center

location_facility: Baylor: Charles A. Sammons Cancer Center

location_facility: Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly

location_facility: Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I

location_facility: Federal State Budgetary Institution Hematology Scientific Centre of Ministry of

location_facility: Pharmacy Nottingham University Hospital - City Hospital Campus

location_facility: SI"Research Center for Radiation Medicine of NAMS of Ukraine"

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: University of Kentucky Markey Cancer Center

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center

location_facility: Klaipeda Seamen's Hospital, Public Institution, department of Oncology

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont

location_facility: OU Medical Center Presbyterian Professional Building

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Department of Oncology and Medical Radiology of State Institution

location_facility: Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust

location_facility: Peggy and Charles Stephenson Cancer Center (chemo & infusion)

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia