CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use
of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly
treated, patients have a good survival. One of the major problems related to its treatment is
the the high rate of relapses after stopping therapy that has lead to biochemical and
histological remissions, close to 80%. Many authors recommend continuous treatment throughout
life, resulting in the occurrence of many side effects. Chloroquine is a drug with
anti-inflammatory properties already used in the treatment of other extrahepatic autoimmune
liver diseases. There are some reports in the literature about its beneficial use in liver
diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune
hepatitis, in which its use was associated with a 6.49 times lower risk of disease recurrence
when compared with patients in whom treatment was discontinued after remission. Our purpose
is to investigate, in a double-blind randomized trial with placebo, whether chloroquine
prevents the recurrence of AIH in patients with histological remission after discontinuation
of conventional treatment and to evaluate the occurrence of side effects.