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NCT02889757 Clinical Trial

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

Protective Effect in TB-DIH Clinical Trial

Official title:
the Safety and Effect in TB Patients With NAC

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02889757
Other study ID # T-6621
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 31, 2016
Last updated September 9, 2016
Start date January 2017
Est. completion date June 2019

Study information
Verified date September 2016
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date June 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Acteylcysteine
randomized into three arms

Locations
Country Name City State
Taiwan Far Eastern Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of DIH the rate for during the 6 months treatment Yes
Secondary the incidence for other side effects side effects including GI upset, blurred vision, neuropathy, renal organ damage 6 months Yes