Chronic Hepatitis C
Conditions
Keywords
Hepatitis C, Chronic, Genotype 2 or 3, Treatment naive
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 Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 OR 3
Interventions
DRUGAlbuferon
DRUGRibavirin
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy end point is sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy. | — |
| Primary safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities. | — |
Countries
Canada
Outcome results
None listed