Hepatitis, Autoimmune Clinical Trial
Official title:
DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITIS
Verified date | October 2016 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | June 2015 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo School of Medicine | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Mucenic M, Mello ES, Cançado EL. Chloroquine for the maintenance of remission of autoimmune hepatitis: results of a pilot study. Arq Gastroenterol. 2005 Oct-Dec;42(4):249-55. Epub 2006 Jan 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of autoimune hepatitis after treatment withdrawal in patients maintained only with chloroquine | To evaluate the rate of recurrence of autoimmune hepatitis with histological remission after withdrawal of corticosteroids and immunosuppressive drugs and after introduction of maintenance therapy with chloroquine or placebo. Recurrence is defined by the sustained increase or progressive liver enzymes above twice the upper normal reference value (as defined by the criteria of the International Autoimmune Hepatitis) in at least two different dosages taken with an interval of 15 to 30 days. | thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine | Yes |
Secondary | Side effects of chloroquine | To assess the occurrence of side effects of chloroquine and to evaluate if the use of chloroquine has a cost benefit for maintenance of remission histological, we will investigate hematological, dermatological, opthalmological, neurological, musculoeskeletal and gastrintestinal symptoms. To evaluate the ocular toxicity, patients will undergo ophthalmic evaluation to detect retinal deposits of chloroquine every six months. Other side effects will be assessed in each medical consultation from the speech of patients and clinical examination.If necessary exams will be performed to confirm the diagnosis (eg electromyography in cases of suspected peripheral neuropathy by chloroquine) | thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine | Yes |
Secondary | Side effects of chloroquine | To assess the occurrence of side effects of chloroquine and to evaluate if the use of chloroquine has a cost benefit for maintenance of remission histological. We will investigate hematological, dermatological, opthalmological, neurological, musculoeskeletal and gastrintestinal symptoms. To evaluate ocular toxicity, patients will undergo ophthalmic evaluation to detect retinal deposits of chloroquine every six months. Other side effects will be assessed in each medical consultation from the talking of patients and clinical examinations. If necessary, other complementary exams will be performed to confirm the diagnosis (for instance, electromyography in cases of suspected peripheral neuropathy by chloroquine). |
thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine | Yes |
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