Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Phase 3

Withdrawn

• Conditions: Hepatitis C Virus (HCV)
• Interventions: Biological: Pegylated Interferon Lambda; Biological: Pegylated Interferon Alfa-2a; Drug: Ribavirin

• Registration Number: NCT01447394
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03
• Study Start: 2012-03
• Primary Completion: 2014-03
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic hepatitis C, Genotype 1 or 4
• HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
• Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
• Naive to prior anti-HCV therapy

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Exclusion Criteria

• Infected with HCV other than Genotype 1 or 4
• Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Use of hematologic growth factors within 90 days prior to study randomization
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Pegylated Interferon Lambda + Ribavirin	Pegylated Interferon Lambda	-
Arm 1: Pegylated Interferon Lambda + Ribavirin	Ribavirin	-
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin	Pegylated Interferon Alfa-2a	-
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin	Ribavirin	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response	At follow-up Week 24 (SVR24) following 48 weeks of treatment
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities	From Day 1 to end of Week 48 on-treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms	From Day 1 to end of Week 48 on-treatment

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Birmingham, West Midlands, United Kingdom