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Hepatotoxicity of Antituberculosis Therapy (HAT) Study (HAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159441
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, 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.

Condition or disease Intervention/treatment
Chemical and Drug Induced Liver Injury 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Hepatotoxicity of Antituberculosis Therapy in a Real-World Setting: an Observational Study in China
Estimated Study Start Date : December 5, 2019
Estimated Primary Completion Date : December 5, 2020
Estimated Study Completion Date : June 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions


Intervention Details:
  • Other: None intervetion
    None intervetion


Primary Outcome Measures :
  1. Proportion of DILI in antituberculosis therapy [ Time Frame: 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 :
  1. Proportion of liver injury of based liver disase,liver failure and adjustment of chemotherapy [ Time Frame: 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.


Biospecimen Retention:   None Retained
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159441


Contacts
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Contact: Wenhong Zhang 13801844344 zhangwenhong@fudan.edu.cn
Contact: Taoping Weng 18817583793

Sponsors and Collaborators
Huashan Hospital
Investigators
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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 Hangzhou Red Cross Hospital
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
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Responsible Party: Wen-hong Zhang, Director of Division of Infectious Diseases, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04159441    
Other Study ID Numbers: RWD-017
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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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
Keywords provided by Wen-hong Zhang, Huashan Hospital:
Hepatotoxicity of Antituberculosis Therapy
DILI
Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning