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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chloroquine Plus Prednisone

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 Plus Prednisone

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


Participant Flow:   Overall Study
    Chloroquine Plus Prednisone   Azathioprine Plus Prednisone
STARTED   26   31 
COMPLETED   10   25 
NOT COMPLETED   16   6 
Adverse Event                4                2 
Lost to Follow-up                1                1 
Pregnancy                2                3 
Lack of Efficacy                6                0 
Physician Decision                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Chloroquine Plus Prednisone

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 Plus Prednisone

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 Total of all reporting groups

Baseline Measures
   Chloroquine Plus Prednisone   Azathioprine Plus Prednisone   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   31   57 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.54  (15.99)   37.23  (17.63)   37.28  (16.84) 
Gender 
[Units: Participants]
Count of Participants
     
Female   21   24   45 
Male   5   7   12 


  Outcome Measures

1.  Primary:   Biochemical Response to Therapy   [ Time Frame: six months ]

2.  Secondary:   Histopathological Response to Therapy   [ Time Frame: liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: lydiatmf@yahoo.com.br



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