Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Sponsor study identifier
interventional
57
0 countries
N/A
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
July 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 18, 2015
Actual (reported)June 2015
Actual (reported)June 4, 2015
Actual (reported)July 2016
Actual (reported)December 30, 2016
Actual (reported)Biochemical Response to Therapy
The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.
six months
Histopathological Response to Therapy
liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response
Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses
One pill of chloroquine diphosphate per day until the end of the study
Prednisone 5-15 mg/day until the end of the study
T de Moraes Falcao L, Terrabuio DRB, Diniz MA, da Silva Evangelista A, Souza FG, R Cancado EL. Efficacy and safety of chloroquine plus prednisone for the treatment of autoimmune hepatitis in a randomized trial. JGH Open. 2019 Sep 10;4(3):371-377. doi: 10.1002/jgh3.12258. eCollection 2020 Jun.
Eduardo LR Cançado
University of Sao Paulo General Hospital
57 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2015
First Posted
June 4, 2015
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
azathioprine 1-2mg/Kg/day until the end of the study
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Primary Completion
June 2015
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
February 15, 2017
Results First Posted
December 30, 2016
Record last verified: 2016-12
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