Drug-induced Liver InjuryNCT02061826
Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
An observational study of Drug-induced Liver Injury, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-induced Liver Injury
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Apr 2017
- How long will I take part?
- 3 Years
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample and primary care clinic
Who may be able to join
- Males and females between the age of 18 to 70 years
- Women in child-bearing period taking some contraception measures
- Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
- Written informed consent can be obtained, some patients agree with liver biopsy
Who cannot join
- Viral hepatitis
- Alcoholic liver disease or non-alcoholic liver disease
- Wilson's disease or other inherited metabolic liver diseases
- Auto-immune liver diseases
- Any dysfunction of liver
- Malnutrition
- Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
- Patients who can not complete follow-ups on time
Trial locations and contacts
1 site in 1 country.
Wen Xie, master contact
China1 site
Beijing Ditan Hospital
Beijing, 100015
Hong Zhao, master, +86 84322816
About this study
Official title: Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.
Read the detailed description
Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.
- Conditions
- Drug-induced Liver Injury
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
histological features of drug-induced liver injury obtained by liver biopsy
Liver biopsy is the main method
Measured: within six months of the DILI onset date
clinical features of drug-induced liver injury assessed by serum parameters of liver function
serum parameters of liver function is the focus
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-induced Liver InjuryStudies of the same condition, open and under way.
- 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-control
- Enrolment
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Xie, Beijing Ditan Hospital
- Investigators
- Wen Xie, master, Study director, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061826
- Sponsor's protocol ID
- Ditan-2014-01
- Status last verified
- Feb 2014
- First submitted
- 26 Jan 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
- ClinicalTrials.gov ID
- NCT02061826
- Acronym / sponsor ID
- Ditan-2014-01
- Conditions
- Drug-induced Liver Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- 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.
The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.
Detailed description
Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.
Study design
- Observational model
- Case-control
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample and primary care clinic
Key inclusion criteria (4 listed)
- Males and females between the age of 18 to 70 years
- Women in child-bearing period taking some contraception measures
- Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
- Written informed consent can be obtained, some patients agree with liver biopsy
Key exclusion criteria (8 listed)
- Viral hepatitis
- Alcoholic liver disease or non-alcoholic liver disease
- Wilson's disease or other inherited metabolic liver diseases
- Auto-immune liver diseases
- Any dysfunction of liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
histological features of drug-induced liver injury obtained by liver biopsy
Time frame: within six months of the DILI onset date
Liver biopsy is the main method
clinical features of drug-induced liver injury assessed by serum parameters of liver function
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
serum parameters of liver function is the focus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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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.
Wen Xie, master contact
Wen Xie, master study director
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-induced Liver Injury, run by Beijing Ditan Hospital at 1 site in China.
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 4 inclusion and 8 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 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Wen Xie, master (+86 84322816), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological features of drug-induced liver injury obtained by liver biopsy (time frame: within six months of the DILI onset date). The study lists 2 primary outcomes in all. 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 19 Feb 2014.