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Hepatotoxicity of Antituberculosis Therapy (HAT) Study

NCT ID: NCT04159441

Last Updated: 2019-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-05

Study Completion Date

2021-06-05

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.

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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.

Conditions

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Chemical and Drug Induced Liver Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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None intervetion

None intervetion

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Director of Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenhong Zhang

Role: STUDY_CHAIR

Huashan Hospital

Yongguo LI

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Dapeng Bai

Role: PRINCIPAL_INVESTIGATOR

Haihe Hospital in Tianjin

Meiying Wu

Role: PRINCIPAL_INVESTIGATOR

The Fifth Hospital in Suzhou

Huaicheng Wang

Role: PRINCIPAL_INVESTIGATOR

Third People's Hospital in Changzhou

Qinfang Ou

Role: PRINCIPAL_INVESTIGATOR

Fifth Hospital in Wuxi

Yonglan Pu

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital in Taicang

Fan Xia

Role: PRINCIPAL_INVESTIGATOR

The 905th Hospital of the PLA Navy

Yuanyuan Chen

Role: PRINCIPAL_INVESTIGATOR

Red Cross Hospital, Hangzhou, China

Zumo Zhou

Role: PRINCIPAL_INVESTIGATOR

People's Hospital in Zhuji

Xiaohong Chen

Role: PRINCIPAL_INVESTIGATOR

Fuzhou Pulmonary Hospital in Fujian

Guofang Deng

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital in Shenzhen

Shiwu Ma

Role: PRINCIPAL_INVESTIGATOR

People's Liberation Army Joint Service Support Unit 920 Hospital (formerly Kunming General Hospital of Chengdu Military Region)

Youfang Gao

Role: PRINCIPAL_INVESTIGATOR

People's Hospital in Haozhou

Yongfang Jiang

Role: PRINCIPAL_INVESTIGATOR

Central South University Xiangya Second Hospital

Hongying Yu

Role: PRINCIPAL_INVESTIGATOR

Huaihua First People Hospital in Hunan

Bo Chen

Role: PRINCIPAL_INVESTIGATOR

Longtan Hospital in Guangxi

Weiqiang Zheng

Role: PRINCIPAL_INVESTIGATOR

Guangdong Medical University Affiliated Hospital

Liyuan Zhang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Hainan Medical College

Guanghui Xu

Role: PRINCIPAL_INVESTIGATOR

Tuberculosis Control Center in Jiangmen

Anjie Zhang

Role: PRINCIPAL_INVESTIGATOR

Yubei Second People's Hospital

Hancheng Liang

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital in Dongguan

Yuqing Wu

Role: PRINCIPAL_INVESTIGATOR

Chest Hospital in Jiangxi

Xilin Zhang

Role: PRINCIPAL_INVESTIGATOR

The Forth People's Hospital in Foshan

Central Contacts

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Wenhong Zhang

Role: CONTACT

[email protected]
13801844344

Taoping Weng

Role: CONTACT

18817583793

Other Identifiers

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RWD-017

Identifier Type: -

Identifier Source: org_study_id

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