Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in US. However, in Brazil the response to these treatments seems to be worse, approximately 35% in five years. Because of the side effects of the gold-standard treatment and the need for an alternative option for the no responsive patients, news drugs must be evaluated for this proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the treatment of rheumatological diseases for at the least five decades. Chloroquine was used as a single drug for up to two years for the maintenance of AIH remission in an open study. There was a 6.49 greater chance of relapse in the historical controls when compared with patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to investigate whether chloroquine in conjunction with prednisone can be used as an alternative treatment of AIH in a randomized study, and to evaluate its side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Azathioprine; Chloroquine; Chloroquine diphosphate; Prednisone

Criteria

Inclusion Criteria:

• Diagnosis of autoimmune hepatitis according to Autoimmune Hepatitis International Group with indication for treatment

• No evidence of decompensated liver cirrhosis

• Non-pregnant women and women with no intention to become pregnant

• Willing to participate in the study

Exclusion Criteria:

• Discrete biochemical changes and histological inflammatory activity absent / minimal (periportal / peri-septal: 0/1 +) or decompensated cirrhosis

• Cases of loss of follow up