Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

Hepatitis C Virus (HCV) Clinical Trial

— PRINCIPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616524
• Other study ID #: AI452-017
• Secondary ID: 2011-004885-14
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2012
• Last updated: September 23, 2015
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilNew Zealand: MedsafeFinland: Finnish Medicines AgencyFinland: Data Protection BoardFinland: National Advisory Board on Health Care EthicsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Mexico: Federal Commission for Sanitary Risks ProtectionBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentJapan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices AgencyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSouth Korea: Korea Food and Drug Administration (KFDA)Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)Singapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityTaiwan: Department of HealthTaiwan: National Bureau of Controlled DrugsHong Kong: Department of HealthBrazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in ResearchChile: Instituto de Salud Pública de ChileIndia: Central Drugs Standard Control OrganizationIndia: Indian Council of Medical ResearchIndia: Ministry of HealthIndia: Ministry of Science and TechnologyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: Ethics CommitteeGreece: National Organization of MedicinesItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyCanada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Chronic hepatitis C, Genotype 2 or 3

• Naïve to prior anti-HCV therapy

Exclusion Criteria:

• Infected with HCV other than Genotype 2 or 3

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

• Evidence of liver disease other than HCV

• Active substance abuse

• Evidence of decompensated cirrhosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)

Intervention

Biological:
• Pegylated interferon lambda (pegIFN?)
Syringe, Subcutaneous, 180 µg, Once weekly, 24 weeks
• Pegylated interferon lambda (pegIFN?)
Syringe, Subcutaneous, 180 µg, Once weekly, 12 weeks
• Pegylated interferon alfa-2a (pegIFNa-2a)
Syringe, Subcutaneous, 180 µg, Once weekly, 24 weeks

Drug:
• Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
• Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
• Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
• Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Autonoma	Buenos Aires
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	Cordoba
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Prov De Santa Fe	Santa Fe
Argentina	Local Institution	Quilmes	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Clayton Vic	Victoria
Australia	Local Institution	Concord	New South Wales
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Parville	Victoria
Australia	Local Institution	Randwick	New South Wales
Australia	Local Institution	Westmead Nsw	New South Wales
Belgium	Local Institution	Brussels
Belgium	Local Institution	Leuven
Belgium	Local Institution	Liege
Chile	Local Institution	Santiago	Metropolitana
Finland	Local Institution	Hus
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nice Cedex 3
Greece	Local Institution	Athens
Greece	Local Institution	Thessaloniki
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Tai Po
Italy	Local Institution	Firenze
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Novara
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Fukuoka
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Hiroshima-Shi	Hiroshima
Japan	Local Institution	Iruma-gun	Saitama
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Kitakyushu	Fukuoka
Japan	Local Institution	Kobe-shi	Hyogo
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Miyazaki
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Saga
Japan	Local Institution	Saitama
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Takamatsu-shi	Kagawa
Japan	Local Institution	Tsuchiura-shi	Ibaraki
Japan	Local Institution	Wakayama-shi	Wakayama
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	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeongsangnam-do
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Distrito Federal
Mexico	Local Institution	Guadalajara
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico City
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Tlalpan	Distrito Federal
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Leiden
New Zealand	Local Institution	Auckland
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Irkutsk
Russian Federation	Local Institution	Krasnoyarsk
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Samara
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	St. Petersburg
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Yunlin
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Hull	Humberside
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United States	Texas Clinical Research Institute, Llc	Arlington	Texas
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Consultants For Clinical Research	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	The Queen'S Liver Center	Honolulu	Hawaii
United States	St. Luke'S Episcopal Hospital - Baylor College Of Medicine	Houston	Texas
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Clinical Research Centers Of America	Murray	Utah
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Orlando Immunology Center	Orlando	Florida
United States	Orlando Infectious Disease Center	Orlando	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	University Of Pittsburgh Medical Center, Ctr For Liver Diseases	Pittsburgh	Pennsylvania
United States	Medical Associates Research Group	San Diego	California
United States	Precision Research Institute, Llc	San Diego	California
United States	Kaiser Permanente Medical Center	San Francisco	California
United States	University Of California, San Francisco/Sf General Hospital	San Francisco	California
United States	Healthcare Research Consultants	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)		Post-treatment follow-up week 12	No
Secondary	Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]		On-treatment Week 4	No
Secondary	Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)	Hb = Hemoglobin ANC = Absolute neutrophil count	Up to week 12 or week 24	Yes
Secondary	Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)		Up to week 12 or week 24	Yes
Secondary	Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)		Up to week 12 or week 24	Yes
Secondary	Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group		Post-treatment week 24	No
Secondary	Proportion of subjects with on-treatment Serious adverse events (SAEs)		Up to week 12 or week 24	Yes
Secondary	Proportion of subjects with dose reductions		Up to week 12 or week 24	Yes
Secondary	Proportion of subjects who discontinue due to Adverse events (AEs)		Up to week 12 or week 24	Yes
Secondary	Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection		Post-treatment follow-up week 12	No
Secondary	Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)		Up to week 12 or week 24	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form