Hepatotoxicity of Antituberculosis Therapy (HAT) Study (HAT)

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

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 Overview

• Status: Unknown
• Conditions: Chemical and Drug Induced Liver Injury
• Intervention / Treatment: Other: None intervetion

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Wenhong Zhang; Phone Number: 13801844344; Email: zhangwenhong@fudan.edu.cn
• Study Contact Backup: Name: Taoping Weng; Phone Number: 18817583793

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Chair: Wenhong Zhang, Huashan Hospital; Principal Investigator: Yongguo Li, First Affiliated Hospital of Harbin Medical University; Principal Investigator: Dapeng Bai, Haihe Hospital in Tianjin; Principal Investigator: Meiying Wu, The Fifth Hospital in Suzhou; Principal Investigator: Huaicheng Wang, Third People's Hospital in Changzhou; Principal Investigator: Qinfang Ou, Fifth Hospital in Wuxi; Principal Investigator: Yonglan Pu, First People's Hospital in Taicang; Principal Investigator: Fan Xia, The 905th Hospital of the PLA Navy; Principal Investigator: Yuanyuan Chen, Red Cross Hospital, Hangzhou, China; Principal Investigator: Zumo Zhou, People's Hospital in Zhuji; Principal Investigator: Xiaohong Chen, Fuzhou Pulmonary Hospital in Fujian; Principal Investigator: Guofang Deng, The Third People's Hospital in Shenzhen; Principal Investigator: Shiwu Ma, People's Liberation Army Joint Service Support Unit 920 Hospital (formerly Kunming General Hospital of Chengdu Military Region); Principal Investigator: Youfang Gao, People's Hospital in Haozhou; Principal Investigator: Yongfang Jiang, Central South University Xiangya Second Hospital; Principal Investigator: Hongying Yu, Huaihua First People Hospital in Hunan; Principal Investigator: Bo Chen, Longtan Hospital in Guangxi; Principal Investigator: Weiqiang Zheng, Guangdong Medical University Affiliated Hospital; Principal Investigator: Liyuan Zhang, The Second Affiliated Hospital of Hainan Medical College; Principal Investigator: Guanghui Xu, Tuberculosis Control Center in Jiangmen; Principal Investigator: Anjie Zhang, Yubei Second People's Hospital; Principal Investigator: Hancheng Liang, The Sixth People's Hospital in Dongguan; Principal Investigator: Yuqing Wu, Chest Hospital in Jiangxi; Principal Investigator: Xilin Zhang, The Forth People's Hospital in Foshan

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 5, 2019
• Primary Completion (ANTICIPATED): December 5, 2020
• Study Completion (ANTICIPATED): June 5, 2021

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (ACTUAL): November 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hepatotoxicity of Antituberculosis Therapy; DILI
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Liver Diseases; Drug-Related Side Effects and Adverse Reactions; Poisoning; Chemical and Drug Induced Liver Injury
• Other Study ID Numbers: RWD-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No