Trials / Completed
CompletedNCT00115908
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 458 (actual)
- Sponsor
- Human Genome Sciences Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Albuferon | |
| DRUG | Ribavirin | |
| DRUG | PEG-IFNalfa2a |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2007-05-01
- Completion
- 2007-05-01
- First posted
- 2005-06-27
- Last updated
- 2013-11-07
Locations
87 sites across 8 countries: Australia, Canada, Czechia, France, Germany, Israel, Poland, Romania
Source: ClinicalTrials.gov record NCT00115908. Inclusion in this directory is not an endorsement.