Hepatotoxicity of Antituberculosis Therapy (HAT) Study

Chemical and Drug Induced Liver Injury Clinical Trial

— HAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04159441
• Other study ID #: RWD-017
• Status: Not yet recruiting
• Start date: December 5, 2019
• Est. completion date: June 5, 2021

Study information

• Verified date: November 2019
• Source: Huashan Hospital
• Contact: Wenhong Zhang
• Phone: 13801844344
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: June 5, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury

Intervention

Other:
• None intervetion
None intervetion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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