Status:
COMPLETED
A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis C Genotype 2 or 3.
Detailed Description
A Randomized, Multi-Center, Open-Label Study To Evaluate The Efficacy And Safety Of Albuferon (HGS 1008, Recombinant Human Albumin-Interferon Alfa Fusion Protein) In Combination With Ribavirin In Inte...
Eligibility Criteria
Inclusion
- Have a clinical diagnosis of chronic hepatitis C on the basis of detectable serum HCV RNA during the screening period and at least a 6-month history of exposure to risk factors for HCV.
- Have never received treatment with an interferon alfa product or an interferon alfa combination product.
- Have HCV genotype 2 or 3.
- Have compensated liver disease with the following minimum criteria: white blood cell count (WBC) \>3,000/mm3, absolute neutrophil count (ANC) \> 1,800/mm3, platelets \>100,000/mm3, hemoglobin (Hb) \> 13 g/dL for males and \> 12 g/dL for females.
Exclusion
- Evidence of decompensated liver disease.
- 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 :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00656006
Start Date
November 1 2005
End Date
April 1 2007
Last Update
August 2 2013
Active Locations (6)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
3
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3P1
4
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 2P4