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Mucomyst for Hepatitis C

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ClinicalTrials.gov Identifier: NCT00493610
Recruitment Status : Suspended (Collaborator no longer interested, short of funds)
First Posted : June 28, 2007
Last Update Posted : January 8, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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
Hepatitis C Drug: N-acetylcysteine(Mucomyst)

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Study Design

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00493610


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

Responsible Party: Saklayen, Mohammad - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov 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
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
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes