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

Human Genome Sciences

Status and phase

Completed

Phase 2

Conditions

Hepatitis C, Chronic

Treatments

Drug: PEG-IFNalfa2a

Drug: Albuferon

Drug: Ribavirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00115908

ALFR-HC-04

Details and patient eligibility

About

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.

Enrollment

458 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.