Hepatotoxicity of Antituberculosis Therapy (HAT) Study

Study Overview
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Brief Summary
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Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.

Detailed Description
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Drug-induced liver injury (DILI) is a common side effect in antituberculosis therapy, which interuputs the treatment of TB and leads to a higher proportion of Multidrug-Resistence TB(MDR-TB).The study primalily aims to observe the proportion of DILI in antituberculosis therapy. Furthermore, the secondary objective is to study the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy in the obersevational study.

Official Title
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Hepatotoxicity of Antituberculosis Therapy in a Real-World Setting: an Observational Study in China

Conditions
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Chemical and Drug Induced Liver Injury

Intervention / Treatment
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* Other: None intervetion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Patients who are about to start anti-tuberculosis treatment 2) Male or female, age > 18 years old 3) Voluntary signing of Subject Informed Consent Form Exclusion Criteria: - 1)A history of taking anti-tuberculosis drugs within 6 months before the treatment; 2)Abnormal liver function before starting anti-tuberculosis treatment; 3)DILI at the time of enrollment. 4)Combined with malignant tumors (including hematological tumors), HIV infection, etc. 5) According to the investigator's judgment, patients who cannot complete this study or who cannot comply with the requirements of this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None intervetion|None intervetion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of DILI in antituberculosis therapy | The study primalily aims to observe the proportion of DILI in antituberculosis therapy,by monitoring and following up the liver function of the participants. | 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy | The study secondly aims to observe the proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy,by monitoring and following up the liver function, drug treatment of the participants. | 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatotoxicity of Antituberculosis Therapy, DILI