A study for the relationship between polymorphism of NAT-2 genotype and anti-tuberculosis drug-induced liver injury

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900026138

Enrollment

Unknown

Registered

2019-09-23

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anti-tuberculosis drug-induced liver injury

Interventions

Hepatic injury group :N/A

non-injury group :N/A

Eligibility

Sex/Gender

All

Age

No minimum to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 0-70 years old; 2. No Gender limitation; 3. Compliance with diagnostic criteria for newly diagnosed tuberculosis and standard anti-tuberculosis treatment regimen (2HRZE/4HR) ; 4. Except for tuberculosis caused by isoniazid-resistant tuberculosis bacteria; 5. Sign informed consent. The case group met the diagnostic criteria of drug-induced liver injury caused by antituberculosis drugs. ALT >= 3ULN and(or)DBIL >= 2ULN or AST ALP and DBIL simultaneously elevated with at least one >=2ULN. Control group: No liver injury occurred during anti-tuberculosis treatment.

Exclusion criteria

Exclusion criteria: 1. Liver dysfunction existed before antituberculosis treatment. 2. There are other diseases that can cause abnormal liver function. 3. Take other drugs that may cause liver dysfunction. 4. Retreated and drug-resistant tuberculosis patients. 5. Persons with isoniazid contraindication. 6. Complication of hepatitis A, B, C, E or HIV infection or autoimmune liver disease, alcoholic liver disease, metabolic liver disease and other basic liver diseases. 7. Pregnant and lactating women. 8. Subjects withdraw informed consent. 9. Doctors believe that the subjects are unsuitable for continuing this clinical study. 10. Other serious medical diseases (severe respiratory and circulatory insufficiency, immunodeficiency, organ transplantation other than corneal transplantation or hair transplantation) and past history of mental illness 11. Participation in other clinical researchers in the past three months. 12. Any researcher considers that it may affect patients'enrollment or participation in and completion of the experiment.

Design outcomes

Primary

Measure	Time frame
NAT2 genotype;	—

Countries

China

Contacts

Public ContactLu Shuihua

Shanghai Public Health Clinical Center

lushuihua66@126.com+86 18930811818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026