A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

Human Genome Sciences

Status and phase

Completed

Phase 2

Conditions

Hepatitis C

Treatments

Drug: Ribavirin

Drug: Albuferon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097435

Clinical Protocol ALFR-HC-05

Details and patient eligibility

About

This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.

Enrollment

115 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
Have previously failed to respond to treatment with any interferon alfa (IFNa) product
Have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (ANC) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (Hb) > 13 g/dL for males or > 12 g/dL for females.

Major Exclusion Criteria:

Evidence of decompensated cirrhosis or portal hypertension.
Pregnant or lactating female.
History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
A current drug or alcohol addiction