CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria: - diagnosis of autoimmune hepatitis according to Autoimmune Hepatitis International Group

• histological remission during treatment with immunosuppressive drugs (Liver biopsy with periportal inflammatory activity less than 2)

• 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:

• patients who needed to suspend the drug under six months of the medication because of side effects or the patient's desire

• cases of loss of follow up