A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00157534
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Celgosivir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Dose-Ranging, Open-Label, Multi-Centre Study to Evaluate the Safety and Efficacy of Celgosivir for 12 Weeks in Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics Inc:

Primary Outcome Measures:
  • Safety analysis

Secondary Outcome Measures:
  • Hepatitis C viral load

Estimated Enrollment: 43
Study Start Date: October 2004
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be 18 to 65 years of age, inclusive.
  • Primary diagnosis of chronic HCV infection.

Exclusion Criteria:

  • Patients who did not respond or relapsed following therapy with interferon.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157534

Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157534     History of Changes
Other Study ID Numbers: HCV-04-001
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: Canada: Health Canada

Keywords provided by BioWest Therapeutics Inc:
Hepatitis C
Celgosivir
HCV
Genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 22, 2014