CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 48mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02651350
NCT02651350Phase 2Completed
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A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury

Beijing 302 Hospital·interventional·Posted Jan 11, 2016·Updated Aug 11, 2020

In Brief

A Phase 2 clinical trial evaluating Methylprednisolone and Standard Treatment for Drug-induced Liver Injury,Chronic. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This study is to observe the efficacy and safety of glucocorticosteroid treatment in the patients with chronic recurrent drug-induced liver injury (DILI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug-induced Liver Injury,Chronic
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 11, 2016
Enrollment StartDec 1, 2015
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.5 years ago

Interventions

Methylprednisolonedrug

Participants will receive methylprednisolone,48mg/d for the 1st week,32mg/d for the 2nd week,24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal.Participants will also receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA) in the first 12 weeks.The total treatment duration will be 48 weeks. Follow-up duration is 24 weeks.

Standard Treatmentdrug

Participants will only receive standard treatment,namely,routine liver protection drugs including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) from week 0 through week 12 study visit. Participants will then be followed until week 72.