A 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

NCT00217139

HCV-05-002

Details and patient eligibility

About

The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)