Mucomyst for Hepatitis C

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. Identifier: NCT00493610
Recruitment Status : Suspended (Collaborator no longer interested, short of funds)
First Posted : June 28, 2007
Last Update Posted : January 8, 2010
West Virginia University
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: N-acetylcysteine(Mucomyst) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Drug: N-acetylcysteine(Mucomyst)

Primary Outcome Measures :
  1. Measurable oxidant stress [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Reduction in viral load of Hep C and changes in Liver Function tests [ Time Frame: 30 days ]

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 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00493610

United States, Ohio
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
Sponsors and Collaborators
VA Office of Research and Development
West Virginia University
Principal Investigator: Mohammad G. Saklayen, MD VA Medical Center, Dayton

Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs Identifier: NCT00493610     History of Changes
Other Study ID Numbers: 0031
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: June 2008

Keywords provided by VA Office of Research and Development:
Oxidant stress
Hepatitis C
Liver disease

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs