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
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
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
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Florida at Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Florida CRC
🇺🇸Gainesville, Florida, United States