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The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)

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ClinicalTrials.gov Identifier: NCT02889757
Recruitment Status : Unknown
Verified September 2016 by Shih-Lung Cheng, Far Eastern Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital

Study Description
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Brief Summary:

Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However, there are few published data and large sample sizes regarding the protective effect of NAC against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.

Therefore, the investigators designed a clinical trial with the aim to see whether NAC could protect against anti-TB drug-induced hepatotoxicity (DIH)


Condition or disease Intervention/treatment Phase
Protective Effect in TB-DIH TB-DIH Means: Drug Induced Liver Function Abnormalities Drug: Acteylcysteine Phase 4

Detailed Description:

Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), the first-line drugs used for tuberculosis (TB) chemotherapy, are associated with hepatotoxicity. A high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. Sharifzadeh et al. reported an incidence of 27.7% in Iran. The reasons for this higher rate of hepatotoxicity are not completely clear. Ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis B and C virus, HIV infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (DIH) because of anti-TB treatment.

The mechanism of DIH induced by anti-TB treatment is not yet fully understood. Sodhi et al. proposed oxidative stress as one of the likely mechanisms for INH-RIF-induced hepatic injury. It is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (GSH), cells can be protected against oxidative injuries produced by various drugs and chemicals.

The study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-TB agents and using NAC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: the Safety and Effect in TB Patients With NAC
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: NAC 1200 mg
patients with add NAC (600) 1# bid use per day during the study period
 Drug: Acteylcysteine
randomized into three arms
Experimental: NAC 2400 mg
patients with add NAC (600) 2# bid use per day during the study period
 Drug: Acteylcysteine
randomized into three arms
Placebo Comparator: NAC 0 mg
patients with add NAC (600) 0# (placebo) use per day during the study period
 Drug: Acteylcysteine
randomized into three arms


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of DIH [ Time Frame: during the 6 months treatment ]
    the rate for


Secondary Outcome Measures :
  1. the incidence for other side effects [ Time Frame: 6 months ]
    side effects including GI upset, blurred vision, neuropathy, renal organ damage


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. new diagnosed to have tuberculosis
  2. age >20 years -

Exclusion Criteria:

  1. acute hepatitis in a previous one year
  2. TB drugs induced urticaria or Steven-Johnson syndrome
  3. life less than one year due to advanced cancer status
  4. non-tuberculosis mycobacteria，NTM patients
  5. HIV patients
  6. patients can not cooperate
  7. Allergic reaction for NAC
Contacts and Locations
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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): NCT02889757


Locations
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Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Far Eastern Memorial Hospital
More Information
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Responsible Party: Shih-Lung Cheng, Associate Professor, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02889757    
Other Study ID Numbers: T-6621
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shih-Lung Cheng, Far Eastern Memorial Hospital:
tuberculosis
acetylcysteine
hepatotoxicity
Additional relevant MeSH terms:
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Congenital Abnormalities