A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

Human Genome Sciences Inc.8 sites in 1 country115 target enrollmentOctober 2004

ConditionsHepatitis C

DrugsAlbuferon Ribavirin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis C
Sponsor: Human Genome Sciences Inc.
Enrollment: 115
Locations: 8
Primary Endpoint: The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

August 2007

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Human Genome Sciences Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.

Secondary Outcomes

Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.