Clinical trial NCT04159441: Hepatotoxicity of Antituberculosis Therapy (HAT) Study
Official title: Hepatotoxicity of Antituberculosis Therapy in a Real-World Setting: an Observational Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemical and Drug Induced Liver Injury
Keywords: Hepatotoxicity of Antituberculosis Therapy
DILI
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are about to start anti-tuberculosis treatment in the real world, including combined with different kinds of based disease, such as viral hepatitis,systematic infection,etc.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of DILI in antituberculosis therapy
timeFrame: 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation
Secondary outcomes:
measure: Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy
timeFrame: 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Wenhong Zhang
role: STUDY_CHAIR
affiliation: First Affiliated Hospital of Harbin Medical University
name: Yongguo LI
role: PRINCIPAL_INVESTIGATOR
affiliation: Haihe Hospital in Tianjin
name: Dapeng Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: The Fifth Hospital in Suzhou
name: Meiying Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Third People's Hospital in Changzhou
name: Huaicheng Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Fifth Hospital in Wuxi
name: Qinfang Ou
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital in Taicang
name: Yonglan Pu
role: PRINCIPAL_INVESTIGATOR
affiliation: The 905th Hospital of the PLA Navy
name: Fan Xia
role: PRINCIPAL_INVESTIGATOR
affiliation: Red Cross Hospital, Hangzhou, China
name: Yuanyuan Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital in Zhuji
name: Zumo Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuzhou Pulmonary Hospital in Fujian
name: Xiaohong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third People's Hospital in Shenzhen
name: Guofang Deng
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Liberation Army Joint Service Support Unit 920 Hospital (formerly Kunming General Hospital of Chengdu Military Region)
name: Shiwu Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital in Haozhou
name: Youfang Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University Xiangya Second Hospital
name: Yongfang Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Huaihua First People Hospital in Hunan
name: Hongying Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Longtan Hospital in Guangxi
name: Bo Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Medical University Affiliated Hospital
name: Weiqiang Zheng
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Hainan Medical College
name: Liyuan Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuberculosis Control Center in Jiangmen
name: Guanghui Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Yubei Second People's Hospital
name: Anjie Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sixth People's Hospital in Dongguan
name: Hancheng Liang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chest Hospital in Jiangxi
name: Yuqing Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Forth People's Hospital in Foshan
name: Xilin Zhang
role: PRINCIPAL_INVESTIGATOR
References: