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

Phase 2CompletedNCT00292084

BioWest Therapeutics Inc60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

CelgosivirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Safety analysis

HCV viral load reduction from baseline

Data from ClinicalTrials.gov

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