Status:
COMPLETED
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The st...
Eligibility Criteria
Inclusion
- Key
- Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
- Compensated liver disease
- Key
Exclusion
- Pregnant or lactating female or males with a pregnant partner.
- A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
- A history of moderate, severe or uncontrolled psychiatric disease.
- A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00115908
Start Date
May 1 2005
End Date
May 1 2007
Last Update
November 7 2013
Active Locations (87)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
3
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145