Protective Effect in TB-DIH Clinical Trial
Official title:
the Safety and Effect in TB Patients With NAC
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 |
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)
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Taiwan,
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 |