Mucomyst for Hepatitis C

This study has been suspended.

( Collaborator no longer interested, short of funds )

First Received on June 26, 2007. Last Updated on January 7, 2010 History of Changes

Sponsor:	Department of Veterans Affairs
Collaborator:	West Virginia University
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00493610

Purpose

The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the changes in oxidant stress as measured by different oxidant stress markers level in sera. Secondary outcomes of interest will be changes in viral load of hep C and changes in liver function

Condition	Intervention
Hepatitis C	Drug: N-acetylcysteine(Mucomyst)

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Use of Mucomyst (NAC) to Ameliorate Oxidant Stress as Measured by Surrogate Serum in Patients With Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Hepatitis A Vaccines Acetylcysteine

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Measurable oxidant stress [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in viral load of Hep C and changes in Liver Function tests [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	5
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: N-acetylcysteine(Mucomyst)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Patient with known hepatitis C

Exclusion Criteria:

Patient on another therapy for Hep C
Patient on dialysis
Patient who are allergic to Mucomyst

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493610

Locations

United States, Ohio
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428

Sponsors and Collaborators

Department of Veterans Affairs

West Virginia University

Investigators

Principal Investigator:

Mohammad G. Saklayen, MD

VA Medical Center, Dayton

More Information

No publications provided

Responsible Party:	Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00493610 History of Changes
Other Study ID Numbers:	0031
Study First Received:	June 26, 2007
Last Updated:	January 7, 2010
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Oxidant stress
N-acetylcysteine
Hepatitis C

Liver disease
Mucomyst
Isoprostane

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Acetylcysteine
N-monoacetylcystine

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on February 12, 2012