A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

Phase 2

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00115908
• Lead Sponsor: Human Genome Sciences Inc.

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-26
• Study First Posted: 2005-06-27
• Study First Submitted QC: 2005-06-29
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

• Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
• Compensated liver disease

Key

Exclusion Criteria

• Pregnant or lactating female or males with a pregnant partner.
• A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
• A history of moderate, severe or uncontrolled psychiatric disease.
• A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Secondary Outcome Measures

Name	Time	Method
Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
Undetectable HCV RNA at Week 24.
End of treatment response (ETR), defined as undetectable HCV RNA at Week 48

Trial Locations

Locations (86)

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

John Hunter Hospital; 🇦🇺 New Lambton Heights, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

St. Vincents Hospital; 🇦🇺 East Melbourne, Victoria, Australia

Western Hospital; 🇦🇺 Footscray, Victoria, Australia

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