Mucomyst for Hepatitis C

This study has been suspended.

( Collaborator no longer interested, short of funds )

First Received: June 26, 2007 Last Updated: June 12, 2008 History of Changes

Sponsors and Collaborators:	Department of Veterans Affairs 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)

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Use of Mucomyst (NAC) to Ameliorate Oxidant Stress as Measured by Surrogate Serum in Patients With Hepatitis C

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:	Department of Veterans Affairs ( Saklayen, Mohammad - Principal Investigator )
Study ID Numbers:	0031
Study First Received:	June 26, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00493610 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Oxidant stress
N-acetylcysteine
Hepatitis C

Liver disease
Mucomyst
Isoprostane

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Antioxidants
Digestive System Diseases
Expectorants

Acetylcysteine
Hepatitis, Viral, Human
Stress
Hepatitis C
Antiviral Agents
N-monoacetylcystine

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Liver Diseases
RNA Virus Infections
Antioxidants
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Physiological Effects of Drugs
Hepatitis, Viral, Human
Protective Agents
Antiviral Agents

Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Expectorants
Therapeutic Uses
Free Radical Scavengers
Acetylcysteine
Hepatitis C
N-monoacetylcystine
Antidotes

ClinicalTrials.gov processed this record on May 06, 2009