A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C

April 3, 2008 updated by: BioWest Therapeutics Inc

A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C

The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jim Pankovich
  • Phone Number: 259 604-221-9666

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Recruiting
        • Liver and Intestinal Research Centre
      • Vancouver, British Columbia, Canada, V5Z 1H6
        • Completed
        • Cantest
    • Ontario
      • Toronto, Ontario, Canada, M1L 4S4
        • Recruiting
        • Biovail Contract Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years of age, inclusive
  • primary diagnosis of chronic HCV infection, genotype 1
  • Interferon-based treatment-naïve
  • Body Mass Index of 18 to 30, inclusive

Exclusion Criteria:

  • patients previously treated with Interferon-based therapy
  • patients with diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Celgosivir
400mg qd + standard of care for 12 weeks
Drug: Celgosivir
600mg qd + standard of care for 12 weeks
Experimental: 2
Drug: Celgosivir
400mg qd + standard of care for 12 weeks
Drug: Celgosivir
600mg qd + standard of care for 12 weeks
Active Comparator: 3
Drug: Peginterferon alfa 2b + ribavirin
Standard of care for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety analysis
Time Frame: 12 weeks
12 weeks
HCV viral load
Time Frame: 12 weeks
12 weeks
Pharmacokinetics of celgosivir/castanospermine
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioWest Therapeutics Inc

Investigators

  • Study Director: Jim Pankovich, BioWest Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

June 1, 2006

Study Record Updates

Last Update Posted (Estimate)

April 8, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV-06-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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