A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3
Information source: Human Genome Sciences Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: Albuferon (Drug); Ribavirin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Human Genome Sciences Inc. Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
A Study of Albuferon with Ribavirin in Interferon Alfa Naive Subjects with Chronic Hepatitis
C Genotype 2 or 3.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Primary safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.Primary efficacy end point is sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Calgary, Calgary, Alberta T2N 4N1, Canada
University of Alberta, Edmonton, Alberta T6G 2X8, Canada
University of British Columbia, Vancouver, British Columbia V5Z 3P1, Canada
University of Manitoba, Winnipeg, Manitoba R3E 2P4, Canada
University of Western Ontario, London, Ontario N6A 5A5, Canada
University of Saskatchewan, Saskatoon, Saskatchewan S7N 0W8, Canada
Additional Information
Starting date: November 2005
Last updated: August 1, 2013
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