Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials

Hepatitis C Virus Clinical Trial

Official title:

An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428063
• Other study ID #: AI444-026
• Secondary ID: 2011-000836-27
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2011
• Last updated: February 6, 2015
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilAustria: Federal Office for Safety in Health CareBrazil: National Health Surveillance AgencyBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchCanada: Health CanadaDenmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsEgypt: Institutional Review BoardEgypt: Ministry of Health and PopulationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesGreece: Ethics CommitteeGreece: National Organization of MedicinesIreland: Irish Medicines BoardIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyKorea: Food and Drug AdministrationMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)New Zealand: MedsafePoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsSingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesSweden: Medical Products AgencySweden: The National Board of Health and WelfareSweden: Swedish Data Inspection BoardSweden: Regional Ethical Review BoardTaiwan: Department of HealthTaiwan: National Bureau of Controlled DrugsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.

Description:

• Intervention Model:

• Parallel: for all subjects entering the trial

• Cross-over: for genotype 1b subjects rolling over from AI447-028 who require rescue therapy after initial treatment in this study

• Peginterferon Alfa-2a (pegIFNα-2a)

• Ribavirin (RBV)

• Daclatasvir (DCV)

• Asunaprevir (ASV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to control arm (Peginterferon a/Ribavirin + Placebo) during the trial

• HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)

• HCV RNA viral load detectable

Exclusion Criteria:

• Discontinuation from prior BMS HCV clinical trial due to a Peginterferon/Ribavirin-related event

• Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or BMS-791325

• Positive for Hepatitis B infection (Hepatitis B surface antigen (HBsAg)) or Human immunodeficiency virus 1 (HIV-1)/HIV-2 antibody at screening

• Evidence of medical condition associated with chronic liver disease other than HCV

• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Daclatasvir

• Asunaprevir

• Peginterferon alfa-2a

• Ribavirin

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Prov De Santa Fe	Santa Fe
Argentina	Local Institution	Prov. Buenos Aires	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Clayton Vic	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Perth	Western Australia
Australia	Local Institution	Westmead Nsw	New South Wales
Austria	Local Institution	Graz
Austria	Local Institution	Wien
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vaughan	Ontario
Canada	Local Institution	Victoria	British Columbia
Denmark	Local Institution	Hvidovre
France	Local Institution	Bondy Cedex
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil
France	Local Institution	Creteil
France	Local Institution	Lille
France	Local Institution	Lyon Cedex 02
France	Local Institution	Marseille Cedex 08
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nice Cedex 03
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 13
France	Local Institution	Paris Cedex 14
France	Local Institution	Toulouse
France	Local Institution	Toulouse Cedex 09
France	Local Institution	Vandoeuvre Cedex
France	Local Institution	Villejuif Cedex
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Frankfurt
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Greece	Local Institution	Thesaloniki
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin 8	Dublin
Italy	Local Institution	Brescia
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Messina
Italy	Local Institution	Milano
Italy	Local Institution	Pavia
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Italy	Local Institution	Viale Del Policlinico, 155
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Guadalajara	Jalisco
New Zealand	Local Institution	Auckland
Poland	Local Institution	Bialystok
Poland	Local Institution	Wroclaw
Spain	Local Institution	Barcelona
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Stockholm
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	University Of Colorado Denver And Hospital	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	Digestive Disease Associates, P.A.	Catonsville	Maryland
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Metropolitan Research	Fairfax	Virginia
United States	Uf Hepatology Research At Ctrb	Gainesville	Florida
United States	Baylor College Of Medicine	Houston	Texas
United States	Scripps Clinic	La Jolla	California
United States	Scpmg/ Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Dean Clinic	Madison	Wisconsin
United States	North Shore Long Island Jewish Health System	Manhasset	New York
United States	Schiff Center For Liver Diseases	Miami	Florida
United States	Baptist Medical Center South	Montgomery	Alabama
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Alamo Medical Research	San Antonio	Texas
United States	Washington University School Of Medicine	St. Louis	Missouri
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy based on the proportion of subjects with Sustained virologic response (SVR)12 [HCV Ribonucleic acid (RNA) < LOQ at Follow-up week 12] for all subjects infected with genotype 1 who are prior non-responders to Peginterferon Alfa-2a/Ribavirin		Follow-up Week 12	No
Secondary	Efficacy as determined by the proportion of subjects with SVR12 in genotype 2, 3 & 4 prior non-responders to pegIFNa-2a/RBV and treatment naive genotype 1b		Follow-up Week 12	No
Secondary	Safety measured by frequency of Serious Adverse Event(s) (SAE)s and discontinuations due to Adverse Events (AEs)		At End of Treatment (Week 24) & Follow-up Week 4	Yes
Secondary	Proportion of subjects who achieve HCV RNA < Limit of quantitation (LOQ) (detectable or undetectable) for each HCV genotype and treatment regimen		Weeks 1, 2 , 4, 6, 8 & 12, Weeks 4 and 12 [Virologic Response (VR) (4 & 12)], End of Treatment (Week 24) or Follow-up Week 24 (SVR24)	No
Secondary	Proportion of subjects who achieve HCV RNA undetectable for each HCV genotype and treatment regimen		Week 1, 2, 4, 6, 8 & 12, Weeks 4 and 12 [Extended rapid virologic response (eRVR)], End of Treatment (Week 24), Follow-up week 12 or Follow-up week 24	No
Secondary	Drug-resistant variants associated with virologic failure for each HCV genotype and treatment regimen		End of Trial (Week 48)	No

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