CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS
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ClinicalTrials.gov Identifier: NCT01980745 |
Recruitment Status :
Completed
First Posted : November 11, 2013
Last Update Posted : October 26, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis, Autoimmune | Drug: Chloroquine diphosphate 250mg Drug: Placebo | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITIS |
Study Start Date : | February 2002 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Chloroquine diphosphate
chloroquine diphosphate 250mg/day
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Drug: Chloroquine diphosphate 250mg
Sugar pill (placebo) one pill per day for 1110 days Chloroquine diphosphate 250mg per day for 1110 days |
Placebo Comparator: sugar pill
sugar pill
|
Drug: Placebo |
- Recurrence of autoimune hepatitis after treatment withdrawal in patients maintained only with chloroquine [ Time Frame: thirty-six months after immunosuppressive treatment withdrawal and initial use of 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.
- Side effects of chloroquine [ Time Frame: thirty-six months after immunosuppressive treatment withdrawal and initial use 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)
- Side effects of chloroquine [ Time Frame: thirty-six months after immunosuppressive treatment withdrawal and initial use 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).

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980745
Brazil | |
University of São Paulo School of Medicine | |
Sao Paulo, Brazil, 05403-010 |
Principal Investigator: | Débora R Terrabuio, master | University of Sao Paulo |
Responsible Party: | DÉBORA RAQUEL BENEDITA TERRABUIO, MD, University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT01980745 |
Other Study ID Numbers: |
CAPPesq 0697/07 0697/07 ( Other Identifier: Ethics Committee for Analysis of Research Projects HCFMUSP ) |
First Posted: | November 11, 2013 Key Record Dates |
Last Update Posted: | October 26, 2016 |
Last Verified: | October 2016 |
autoimmune hepatitis recurrence treatment withdrawal chloroquine maintenance of remission |
Hepatitis A Hepatitis Hepatitis, Autoimmune Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepatitis, Chronic Autoimmune Diseases Immune System Diseases Chloroquine Chloroquine diphosphate |
Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents |