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NCT00217139 Clinical Trial

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

Hepatitis C, Chronic Clinical Trial

Official title:
A Phase II, Randomized, Active-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With and Without Ribavirin, for 12 Weeks in Patients With Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-Based Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00217139
Other study ID # HCV-05-002
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 27, 2006
Start date September 2005
Est. completion date September 2006

Study information
Verified date September 2006
Source BioWest Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Celgosivir

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BioWest Therapeutics Inc

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety analysis
Primary HCV viral load
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