Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C
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.
Interventions
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Canada, Czechia, France, Germany, Israel, Poland, Romania
Outcome results
None listed