A Study of Albuferon With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 2 or 3

Phase 2

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00656006
• Lead Sponsor: Human Genome Sciences Inc.

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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-20
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada

University of Western Ontario; 🇨🇦 London, Ontario, Canada

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada