NCT00115908CompletedPhase 2
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
Human Genome Sciences Inc.87 sites in 4 countries458 target enrollmentStarted: May 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Human Genome Sciences Inc.
- Enrollment
- 458
- Locations
- 87
- Primary Endpoint
- Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Interferon treatment naive subjects with chronic hepatitis C, HCV genotype
- •Compensated liver disease
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.
Outcomes
Primary Outcomes
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
Secondary Outcomes
- End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
- 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.
Investigators
Study Sites (87)
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