Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Drug-induced Liver Injury,Chronic
Interventions
DRUG

Methylprednisolone

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.

DRUG

Standard Treatment

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.

Trial Locations (1)

100039

Beijing 302 hospital,China, Beijing

All Listed Sponsors
lead

Beijing 302 Hospital

OTHER

NCT02651350 - Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI | Biotech Hunter | Biotech Hunter