Drug-induced Liver InjuryPhase 4NCT04553003
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
A Phase 4 study testing Glucocorticoids+hepatoprotectant and hepatoprotectant in people with Drug-induced Liver Injury, run by Li Yang at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Drug-induced Liver Injury
- What is being tested?
- Glucocorticoids+hepatoprotectant and hepatoprotectant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Apr 2025
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of DILI
- RUCAM score≥6 and with liver histology
- Meet any of the following conditions:
- TBIL ≥ 10 fold ULN ;
- TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN
Who cannot join
- An chronic onset (≥6 months)
- Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
- with contraindications of glucocorticoid
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Li Yang, MD, +86 18980601276, yangli_hx@scu.edu.cn
Yi Shen, MM, +86 18280097412, 156450779@qq.com
About this study
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
- Conditions
- Drug-induced Liver Injury
- Being tested
- Glucocorticoids+hepatoprotectant, hepatoprotectant
- Keywords
- glucocorticosteroid
- 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.
Glucocorticoids+hepatoprotectantDrug
Also called prednisone, methylprednisolone
Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
hepatoprotectantDrug
Also called Ademetionine1,4-Butanedisulfonate, Polyene Phosphatidyl choline
Participants received hepatoprotectants (i.v.gtt.) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoid+hepatoprotectant group | Experimental | glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d Receives: Drug: Glucocorticoids+hepatoprotectant |
| hepatoprotectant group | Active comparator | hepatoprotectant for 7d Receives: Drug: hepatoprotectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients that AST or ALT decline 25% at day 4
AST or ALT decline 25% at day 4
Measured: Change from Baseline ALT and AST at day4
Secondary outcomes (5)
percentage of patients that AST or ALT decline 50% at day 8
AST or ALT decline 25% at day 8
Measured: Change from Baseline ALT and AST at day8
the time needed when TBIL decline 50%
TBIL decline 50%; time
Measured: up to 2 weeks
incidence of side effects
infection，uncontrolled hypertension or hyperglycemia
Measured: up to 2 years
relapse rate in 12 months after drug withdrawal
relapse rate
Measured: 12 months after drug withdrawal
mortality in 12 months after drug withdrawal
mortality
Measured: 12 months after drug withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Yang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553003
- Sponsor's protocol ID
- LYang
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
- ClinicalTrials.gov ID
- NCT04553003
- Acronym / sponsor ID
- LYang
- Conditions
- Drug-induced Liver Injury
- Keywords
- glucocorticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Li YangUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 17 Sep 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.
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucocorticoid+hepatoprotectant group | Experimental | Drug: Glucocorticoids+hepatoprotectantglucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d |
| hepatoprotectant group | Active comparator | Drug: hepatoprotectanthepatoprotectant for 7d |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of DILI
- RUCAM score≥6 and with liver histology
- Meet any of the following conditions:
Key exclusion criteria (3 listed)
- An chronic onset (≥6 months)
- Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc
- with contraindications of glucocorticoid
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 |
|---|---|---|
| Glucocorticoids+hepatoprotectantAlso: prednisone, methylprednisoloneParticipants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days. | Drug | glucocorticoid+hepatoprotectant group |
| hepatoprotectantAlso: Ademetionine1,4-Butanedisulfonate, Polyene Phosphatidyl cholineParticipants received hepatoprotectants (i.v.gtt.) for 7 days. | Drug | hepatoprotectant group |
Primary outcome
percentage of patients that AST or ALT decline 25% at day 4
Time frame: Change from Baseline ALT and AST at day4
AST or ALT decline 25% at day 4
5 secondary outcomes
percentage of patients that AST or ALT decline 50% at day 8
Time frame: Change from Baseline ALT and AST at day8
the time needed when TBIL decline 50%
Time frame: up to 2 weeks
incidence of side effects
Time frame: up to 2 years
relapse rate in 12 months after drug withdrawal
Time frame: 12 months after drug withdrawal
mortality in 12 months after drug withdrawal
Time frame: 12 months after drug withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Chengdu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids+hepatoprotectant and hepatoprotectant in people with Drug-induced Liver Injury, run by Li Yang 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 5 inclusion and 3 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 29 Apr 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients that AST or ALT decline 25% at day 4 (time frame: Change from Baseline ALT and AST at day4). 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 29 Apr 2022.