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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT02463331
Date of registration:	18/05/2015
Prospective Registration:	No
Primary sponsor:	University of Sao Paulo General Hospital
Public title:	Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Scientific title:	Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Date of first enrolment:	May 2003
Target sample size:	57
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02463331
Study type:	Interventional
Study design:
Phase:	Phase 4

Countries of recruitment

Contacts

Name:	Eduardo LR Cançado
Address:
Telephone:
Email:
Affiliation:	University of Sao Paulo General Hospital

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Hepatitis

Intervention(s)

Drug: Chloroquine diphosphate

Drug: prednisone

Drug: azathioprine

Primary Outcome(s)

Biochemical Response to Therapy [Time Frame: six months]

Secondary Outcome(s)

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

Secondary ID(s)

0571/04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	30/12/2016
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02463331

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