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

Phase 2

Completed

• Conditions: Hepatitis C

• Registration Number: NCT00097435
• Lead Sponsor: Human Genome Sciences Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-11-23
• Study First Submitted QC: 2004-11-23
• Study First Posted: 2004-11-24
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

University of Florida CRC; 🇺🇸 Gainesville, Florida, United States

University of Florida at Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Metropolitan Research; 🇺🇸 Fairfax, Virginia, United States