Trial Outcomes & Findings for Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial (NCT NCT02463331)
NCT ID: NCT02463331
Last Updated: 2017-02-15
Results Overview
The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
six months
Results posted on
2017-02-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
31
|
|
Overall Study
COMPLETED
|
10
|
25
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Pregnancy
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Baseline characteristics by cohort
| Measure |
Chloroquine Plus Prednisone
n=26 Participants
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
n=31 Participants
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
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.54 years
STANDARD_DEVIATION 15.99 • n=5 Participants
|
37.23 years
STANDARD_DEVIATION 17.63 • n=7 Participants
|
37.28 years
STANDARD_DEVIATION 16.84 • n=5 Participants
|
|
Gender
Female
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six monthsThe biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.
Outcome measures
| Measure |
Chloroquine Plus Prednisone
n=26 Participants
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
n=31 Participants
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
|
|---|---|---|
|
Biochemical Response to Therapy
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical responsePopulation: 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.
Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.
Outcome measures
| Measure |
Chloroquine Plus Prednisone
n=14 Participants
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
n=21 Participants
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
|
|---|---|---|
|
Histopathological Response to Therapy
|
4 Participants
|
10 Participants
|
Adverse Events
Chloroquine Plus Prednisone
Serious events: 6 serious events
Other events: 3 other events
Deaths: 0 deaths
Azathioprine Plus Prednisone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chloroquine Plus Prednisone
n=26 participants at risk
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
n=31 participants at risk
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
|
|---|---|---|
|
Eye disorders
machulopatia
|
23.1%
6/26
|
0.00%
0/31
|
Other adverse events
| Measure |
Chloroquine Plus Prednisone
n=26 participants at risk
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
n=31 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
7.7%
2/26
|
3.2%
1/31
|
|
Gastrointestinal disorders
gastric intolerance
|
0.00%
0/26
|
3.2%
1/31
|
|
Nervous system disorders
neuropathy
|
3.8%
1/26
|
0.00%
0/31
|
Additional Information
Lydia Teófilo de Moraes Falcão
Clinic Hospital of University of Sao Paulo
Phone: 55-81-996486935
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place