Hepatotoxicity of Antituberculosis Therapy (HAT) Study

• Conditions: Chemical and Drug Induced Liver Injury

• Registration Number: NCT04159441
• Lead Sponsor: Huashan Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Study First Posted: 2019-11-12
• Last Update Posted: 2019-11-12
• Study Start: 2019-12-05
• Primary Completion: 2020-12-05
• Study Completion: 2021-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy	12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation	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.