Hepatotoxicity of Antituberculosis Therapy (HAT) Study

NCT04159441 | Unknown DMC

• 1 other identifier: RWD-017
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chemical and Drug Induced Liver Injury

Keywords

Hepatotoxicity of Antituberculosis Therapy; DILI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

None intervetion OTHER

None intervetion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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"

You may not qualify if:

• \- 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.
• \) According to the investigator's judgment, patients who cannot complete this study or who cannot comply with the requirements of this study.

Sponsors & Collaborators

• Huashan Hospital: lead

Biospecimen

Retention: NONE RETAINED

Blood

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Wenhong Zhang

  Huashan Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhong Zhang

CONTACT

13801844344; zhangwenhong@fudan.edu.cn

Taoping Weng

CONTACT

18817583793

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: December 5, 2019
• Primary Completion: December 5, 2020
• Study Completion: June 5, 2021
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR