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

Sponsor

Human Genome Sciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00656006

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Albuferon Drug: Ribavirin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Western Ontario	London	Ontario	Canada	N6A 5A5
6	University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 0W8