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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autoimmune Hepatitis
Interventions Drug: Chloroquine diphosphate
Drug: prednisone
Drug: azathioprine
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Hide Arm/Group Description

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study

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

azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses

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

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

Period Title: Overall Study
Started 26 31
Completed 10 25
Not Completed 16 6
Reason Not Completed
Adverse Event             4             2
Lost to Follow-up             1             1
Pregnancy             2             3
Lack of Efficacy             6             0
Physician Decision             3             0
Arm/Group Title Chloroquine Plus Prednisone Azathioprine Plus Prednisone Total
Hide Arm/Group Description

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study

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

azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses

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

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

Total of all reporting groups
Overall Number of Baseline Participants 26 31 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 31 participants 57 participants
37.54  (15.99) 37.23  (17.63) 37.28  (16.84)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 31 participants 57 participants
Female 21 24 45
Male 5 7 12
1.Primary Outcome
Title Biochemical Response to Therapy
Hide Description The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.
Time Frame six months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Hide Arm/Group Description:

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study

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

azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses

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

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

Overall Number of Participants Analyzed 26 31
Measure Type: Count of Participants
Unit of Measure: Participants
14
  53.8%
21
  67.7%
2.Secondary Outcome
Title Histopathological Response to Therapy
Hide Description Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.
Time Frame liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The histological response was only evaluated in the patients with biochemical remission, since in the patients without biochemical response it was already known that there would be activity in the liver tissue.
Arm/Group Title Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Hide Arm/Group Description:

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study

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

azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses

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

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

Overall Number of Participants Analyzed 14 21
Measure Type: Count of Participants
Unit of Measure: Participants
4
  28.6%
10
  47.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Hide Arm/Group Description

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study

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

azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses

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

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

All-Cause Mortality
Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   6/26 (23.08%)   0/31 (0.00%) 
Eye disorders     
machulopatia *  6/26 (23.08%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chloroquine Plus Prednisone Azathioprine Plus Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   3/26 (11.54%)   2/31 (6.45%) 
Gastrointestinal disorders     
gastric intolerance *  0/26 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
neuropathy *  1/26 (3.85%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
hyperpigmentation *  2/26 (7.69%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lydia Teófilo de Moraes Falcão
Organization: Clinic Hospital of University of Sao Paulo
Phone: 55-81-996486935 ext 81
Responsible Party: Lydia Teófilo de Moraes Falcão, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02463331     History of Changes
Other Study ID Numbers: 0571/04
First Submitted: May 18, 2015
First Posted: June 4, 2015
Results First Submitted: November 2, 2016
Results First Posted: December 30, 2016
Last Update Posted: February 15, 2017