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

This study has been completed.

Sponsored by:	MIGENIX Inc.
Information provided by:	MIGENIX Inc.
ClinicalTrials.gov Identifier:	NCT00157534

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 II

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by MIGENIX 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

MIGENIX Inc.

Investigators

Study Director:

Jim Pankovich

MIGENIX Inc.

More Information

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

Keywords provided by MIGENIX Inc.:

Hepatitis C
Celgosivir
HCV
Genotype 1

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009