A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

Sponsor

Human Genome Sciences Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00097435

Collaborator

(none)

115

Enrollment

Locations

Duration (Months)

14.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities. []

Secondary Outcome Measures

Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Major Inclusion Criteria:

Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
Have previously failed to respond to treatment with any interferon alfa (IFNa) product
Have compensated liver disease with the following minimum criteria: white blood cell count > 3,000/mm3, absolute neutrophil count (ANC) > 2,000/mm3, platelets > 125,000/mm3, and hemoglobin (Hb) > 13 g/dL for males or > 12 g/dL for females.

Major Exclusion Criteria:

Evidence of decompensated cirrhosis or portal hypertension.
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	Mayo Clinic	Phoenix	Arizona	United States	85054
2	University of Florida CRC	Gainesville	Florida	United States	32610
3	University of Florida at Jacksonville	Jacksonville	Florida	United States	32209
4	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32216
5	Johns Hopkins University	Baltimore	Maryland	United States	21287
6	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
7	Duke University	Durham	North Carolina	United States	27710
8	Metropolitan Research	Fairfax	Virginia	United States	22031