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

Phase 3

Completed

• Conditions: Hepatitis C Virus (HCV)
• Interventions: Biological: Pegylated interferon lambda (pegIFNλ); Biological: Pegylated interferon alfa-2a (pegIFNα-2a); Drug: Ribavirin; Drug: Placebo matching Daclatasvir; Drug: Daclatasvir

• Registration Number: NCT01616524
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Study Start: 2012-07
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir	Pegylated interferon lambda (pegIFNλ)	-
Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir	Placebo matching Daclatasvir	-
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir	Placebo matching Daclatasvir	-
Arm 2: pegIFNλ + Ribavirin + Daclatasvir	Pegylated interferon lambda (pegIFNλ)	-
Arm 2: pegIFNλ + Ribavirin + Daclatasvir	Ribavirin	-
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir	Pegylated interferon alfa-2a (pegIFNα-2a)	-
Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir	Ribavirin	-
Arm 2: pegIFNλ + Ribavirin + Daclatasvir	Daclatasvir	-
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)	Post-treatment follow-up week 12

Secondary Outcome Measures

Name	Time	Method
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)	Up to week 12 or week 24	Hb = Hemoglobin ANC = Absolute neutrophil count
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection	Post-treatment follow-up week 12
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)	Up to week 12 or week 24
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group	Post-treatment week 24
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]	On-treatment Week 4
Proportion of subjects with on-treatment Serious adverse events (SAEs)	Up to week 12 or week 24
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)	Up to week 12 or week 24
Proportion of subjects who discontinue due to Adverse events (AEs)	Up to week 12 or week 24
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
Proportion of subjects with dose reductions	Up to week 12 or week 24

Trial Locations

Locations (19)

Precision Research Institute, Llc; 🇺🇸 San Diego, California, United States

Medical Associates Research Group; 🇺🇸 San Diego, California, United States

Orlando Infectious Disease Center; 🇺🇸 Orlando, Florida, United States

Gastrointestinal Specialists Of Georgia; 🇺🇸 Marietta, Georgia, United States

The Queen'S Liver Center; 🇺🇸 Honolulu, Hawaii, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Consultants For Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

University Of Pittsburgh Medical Center, Ctr For Liver Diseases; 🇺🇸 Pittsburgh, Pennsylvania, United States

Healthcare Research Consultants; 🇺🇸 Tulsa, Oklahoma, United States

Texas Clinical Research Institute, Llc; 🇺🇸 Arlington, Texas, United States

St. Luke'S Episcopal Hospital - Baylor College Of Medicine; 🇺🇸 Houston, Texas, United States

Local Institution; 🇬🇧 London, United Kingdom

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

Clinical Research Centers Of America; 🇺🇸 Murray, Utah, United States

University Of California, San Francisco/Sf General Hospital; 🇺🇸 San Francisco, California, United States

Kaiser Permanente Medical Center; 🇺🇸 San Francisco, California, United States