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:
Participant gender:
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.