Chemical and Drug Induced Liver InjuryHATNCT04159441
Hepatotoxicity of Antituberculosis Therapy (HAT) Study
An observational study of Chemical and Drug Induced Liver Injury, run by Huashan Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chemical and Drug Induced Liver Injury
- What is being tested?
- None intervetion
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2019to 5 Jun 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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"
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Taoping Weng contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Chemical and Drug Induced Liver Injury
- Being tested
- None intervetion
- Keywords
- Hepatotoxicity of Antituberculosis Therapy, DILI
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None intervetionOther
None intervetion
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start5 Dec 2019 (estimated)
- Primary completion5 Dec 2020 (estimated)
- Study completion5 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemical and Drug Induced Liver InjuryStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, Study chair, Huashan HospitalYongguo LI, Principal investigator, First Affiliated Hospital of Harbin Medical UniversityDapeng Bai, Principal investigator, Haihe Hospital in TianjinMeiying Wu, Principal investigator, The Fifth Hospital in SuzhouHuaicheng Wang, Principal investigator, Third People's Hospital in ChangzhouQinfang Ou, Principal investigator, Fifth Hospital in WuxiYonglan Pu, Principal investigator, First People's Hospital in TaicangFan Xia, Principal investigator, The 905th Hospital of the PLA Navy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159441
- Sponsor's protocol ID
- RWD-017
- Acronym
- HAT
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatotoxicity of Antituberculosis Therapy in a Real-World Setting: an Observational Study in China
- ClinicalTrials.gov ID
- NCT04159441
- Acronym / sponsor ID
- HAT / RWD-017
- Conditions
- Chemical and Drug Induced Liver Injury
- Keywords
- Hepatotoxicity of Antituberculosis Therapy, DILI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 5 Dec 2019 (estimated)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 5 Jun 2021 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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"
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None intervetionNone intervetion | Other | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taoping Weng contact
Wenhong Zhang study chair
Huashan Hospital
Yongguo LI principal investigator
First Affiliated Hospital of Harbin Medical University
Dapeng Bai principal investigator
Haihe Hospital in Tianjin
Questions about this trial
What is this clinical trial studying?
An observational study of Chemical and Drug Induced Liver Injury, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenhong Zhang (13801844344, zhangwenhong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of DILI in antituberculosis therapy (time frame: 12 months(DILI occurs) or 24 months(None-DILI occur) after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.