Drug-induced Liver InjuryNCT04302506
Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury
An observational study of Drug-induced Liver Injury, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug-induced Liver Injury
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Apr 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University was admitted and a liver biopsy was performed from 2014.9 to 2019.9. The patients were clearly diagnosed with drug-induced liver injury. These patients also met the RUCAM score and were diagnosed as DILI.
Who may be able to join
- Have a clear history of taking drugs (Chinese herbal medicine and dietary supplements, NSAIDs, cardio-cerebrovascular drugs, anti-interference drugs, anti-tuberculosis drugs, hormone drugs and others);
- All patients were examined by liver biopsy Patients with clear diagnosis of drug-induced liver injury and clinical diagnosis of DILI who meet the RUCAM score.
Who cannot join
- Combined with various liver diseases, such as viral hepatitis (hepatitis A, B, C, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease;
- Combining other viral infections that may lose liver function, such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV);
- Mental illness;
- Evidence of liver tumors (liver cancer or alpha-fetoprotein> 100 ng / ml).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, Doctor, 8610-84322200 ext. 2489, xieyao00120184@sina.com
About this study
Official title: The Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury
This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.
Read the detailed description
This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.
- Conditions
- Drug-induced Liver Injury
- Keywords
- Drug-induced liver injury, Chronic, regression analysis, ROC curve, Joint diagnosis
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with drug-induced liver injury | Patients who underwent liver biopsy and were diagnosed with drug-induced liver injury were diagnosed as DILI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of chronicity
Chronic rate of drug-induced liver injury
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302506
- Sponsor's protocol ID
- DTXY025
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury
- ClinicalTrials.gov ID
- NCT04302506
- Acronym / sponsor ID
- DTXY025
- Conditions
- Drug-induced Liver Injury
- Keywords
- Drug-induced liver injury, Chronic, regression analysis, ROC curve, Joint diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.
Detailed description
This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with drug-induced liver injury | – | –Patients who underwent liver biopsy and were diagnosed with drug-induced liver injury were diagnosed as DILI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University was admitted and a liver biopsy was performed from 2014.9 to 2019.9. The patients were clearly diagnosed with drug-induced liver injury. These patients also met the RUCAM score and were diagnosed as DILI.
Key inclusion criteria (2 listed)
- Have a clear history of taking drugs (Chinese herbal medicine and dietary supplements, NSAIDs, cardio-cerebrovascular drugs, anti-interference drugs, anti-tuberculosis drugs, hormone drugs and others);
- All patients were examined by liver biopsy Patients with clear diagnosis of drug-induced liver injury and clinical diagnosis of DILI who meet the RUCAM score.
Key exclusion criteria (4 listed)
- Combined with various liver diseases, such as viral hepatitis (hepatitis A, B, C, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease;
- Combining other viral infections that may lose liver function, such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV);
- Mental illness;
- Evidence of liver tumors (liver cancer or alpha-fetoprotein> 100 ng / ml).
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
The rate of chronicity
Time frame: 48 weeks
Chronic rate of drug-induced liver injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
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 2 inclusion and 4 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 10 Mar 2020. 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 Yao Xie, Doctor (86-13501093293, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of chronicity (time frame: 48 weeks). 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 10 Mar 2020.