Status:
COMPLETED
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 int...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00097435
Start Date
October 1 2004
End Date
August 1 2007
Last Update
August 2 2013
Active Locations (8)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
University of Florida CRC
Gainesville, Florida, United States, 32610
3
University of Florida at Jacksonville
Jacksonville, Florida, United States, 32209
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32216