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Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

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ClinicalTrials.gov Identifier: NCT02463331
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : December 30, 2016
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Lydia Teófilo de Moraes Falcão, University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: Chloroquine diphosphate Drug: prednisone Drug: azathioprine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Study Start Date : May 2003
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Active Comparator: chloroquine plus prednisone
Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Drug: Chloroquine diphosphate
One pill of chloroquine diphosphate per day until the end of the study
Other Name: Chloroquine

Drug: prednisone
Prednisone 5-15 mg/day until the end of the study

Experimental: azathioprine plus prednisone
azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses
Drug: prednisone
Prednisone 5-15 mg/day until the end of the study

Drug: azathioprine
azathioprine 1-2mg/Kg/day until the end of the study




Primary Outcome Measures :
  1. Biochemical Response to Therapy [ Time Frame: six months ]
    The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.


Secondary Outcome Measures :
  1. Histopathological Response to Therapy [ Time Frame: liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response ]
    Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of autoimmune hepatitis according to Autoimmune Hepatitis International Group with indication for treatment
  • 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:

  • Discrete biochemical changes and histological inflammatory activity absent / minimal (periportal / peri-septal: 0/1 +) or decompensated cirrhosis
  • Cases of loss of follow up

Information from the National Library of Medicine

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): NCT02463331


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Eduardo LR Cançado University of Sao Paulo General Hospital

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Responsible Party: Lydia Teófilo de Moraes Falcão, Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis: a Randomized Trial, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02463331    
Other Study ID Numbers: 0571/04
First Posted: June 4, 2015    Key Record Dates
Results First Posted: December 30, 2016
Last Update Posted: February 15, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lydia Teófilo de Moraes Falcão, University of Sao Paulo General Hospital:
autoimmune hepatitis
chloroquine
treatment
Additional relevant MeSH terms:
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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
Prednisone
Azathioprine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents