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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:
ClinicalTrials.gov Identifier:
NCT00157534
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioWest Therapeutics Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157534


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

ClinicalTrials.gov Identifier: NCT00157534     History of Changes
Other Study ID Numbers: HCV-04-001
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

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