An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

BioWest Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Celgosivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292084

HCV-05-004

Details and patient eligibility

About

This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed HCV-05-002 only
• 18-65 years of age, inclusive
• Primary diagnosis of chronic HCV infection
• Non-responders to previous pegylated interferon-based therapy

Exclusion criteria

• Patients naive to interferon-based therapy for chronic HCV infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)