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Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

This study has been completed.
Sponsor:
Information provided by:
National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier:
NCT00564642
First received: November 27, 2007
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.


Condition Intervention
Hepatitis
Tuberculosis
 Drug: N Acetylcysteine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Research Institute of Tuberculosis and Lung Disease, Iran:

Primary Outcome Measures:
  • Hepatotoxicity [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: N Acetylcysteine
    1200 mg, BD, 2weeks
    Other Name: ACC
  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two sputum specimens positives for tubercle bacilli on direct smear microscopy
  • No previous anti-TB chemotherapy higher than two weeks
  • Aged 60 years and over
  • Agreement to participate in the study

Exclusion Criteria:

  • Alcohol consumption
  • Viral disease (Hepatitis,...)
  • Abnormal pretreatment LFT level
  • Chronic disease (liver and kidney disease, asthma,...)
  • Additional hepatotoxic drug use
  • HIV positive
  • Liver TB
  • Patient in a moribund state
  • Hemoptysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564642

Locations
Iran, Islamic Republic of
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
Tehran, Iran, Islamic Republic of, 19556
Sponsors and Collaborators
National Research Institute of Tuberculosis and Lung Disease, Iran
Investigators
Principal Investigator: Shadi Baniasadi, PhD National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
  More Information

No publications provided

Responsible Party: Dr. Baniasadi, National Research Institute of Tuberculosis and Lung Disease
ClinicalTrials.gov Identifier: NCT00564642     History of Changes
Other Study ID Numbers: 5344-21-07-86
Study First Received: November 27, 2007
Last Updated: April 21, 2009
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Tuberculosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Acetylcysteine
 N-monoacetylcystine
Antitubercular Agents
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
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013