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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury

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

Detailed Summary: Drug-induced liver injury (DILI) refers to liver diseases caused by drugs and toxic substances. DILI is a clinical event that can be associated with severe outcomes such as acute liver failure. Up to now, approximately 1000 drugs, herbal products, vitamins and illicit compounds are associated with liver injury. Recently, the incidence of DILI is rising. In our hospital, hospitalized patients with DILI was increased from 1.39% in 2002 to 2.31% in 2006, and further up to 3.17% in 2011, which indicated 2.3-folds increase over last ten years.15% to 20% patients with acute DILI are prone to chronic liver disease. For patients with chronic recurrent DILI, routine liver protective treatment was difficult to rescue abnormal liver functions. Moreover, increasing health care costs seriously affect the patient's quality of life. Glucocorticosteroids can inhibit the non-specific inflammation and permeability of the capillary bile duct, limit the activation of T lymphocytes, and selectively inhibit B lymphocytes to produce antibodies, thus preventing or delaying the immune-induced liver injury. Glucocorticoid treatment of severe DILI has accepted some recognition, but the effect of repeated episodes of chronic DILI, due to a lack of randomized controlled studies, is still unclear. Therefore, we shall design two groups on the basis of the ratio of 1:1, namely, glucocorticoid treatment group and standard treatment alone group. Participants in glucocorticoid treatment group 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 in glucocorticoid treatment group also receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) in the first 12 weeks. Participants in standard treatment group will only receive treatment by routine
Sponsor: Beijing 302 Hospital

Current Primary Outcome:

  • The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period [ Time Frame: At week 24 ]
  • The relapse or recurrent rate of illness, namely, appearance of obviously abnormal liver function again during treatment and follow-up period [ Time Frame: At week 72 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Days of normalization of liver functions including serum levels of ALT, AST, TBIL,GGT and ALP. [ Time Frame: From week 1 to week 12 ]
  • The liver histological changes between two liver biopsies [ Time Frame: At week 0 and at week 48 week ]
  • The number of participants with methylprednisolone treatment-related adverse events, such as severe osteopenia, uncontrolled hypertension [ Time Frame: At week 24 and at week 72 ]


Original Secondary Outcome: Same as current

Information By: Beijing 302 Hospital

Dates:
Date Received: December 25, 2015
Date Started: December 2015
Date Completion: December 2018
Last Updated: November 15, 2016
Last Verified: March 2016