Mucomyst for Hepatitis C

This study has suspended participant recruitment.
(Collaborator no longer interested, short of funds)
Sponsor:
Collaborator:
West Virginia University
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00493610
First received: June 26, 2007
Last updated: January 7, 2010
Last verified: June 2008
  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:


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
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 April 17, 2014