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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097435

Enrollment

115

Registered

2004-11-24

Start date

2004-10-31

Completion date

2007-08-31

Last updated

2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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.

Interventions

DRUGAlbuferon

DRUGRibavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026