Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

NCT02463331 | Completed Phase 4 Results DMC

• 1 other identifier: 0571/04
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autoimmune Hepatitis

Keywords

autoimmune hepatitis; chloroquine; treatment

Outcome Measures

Primary Outcomes (1)

• Biochemical Response to Therapy

  The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.

  six months

Secondary Outcomes (1)

• Histopathological Response to Therapy

  liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response

Study Arms (2)

chloroquine plus prednisone

ACTIVE COMPARATOR

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

Drug: Chloroquine diphosphate; Drug: prednisone

azathioprine plus prednisone

EXPERIMENTAL

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

Drug: prednisone; Drug: azathioprine

Interventions

Chloroquine diphosphate DRUG

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

Also known as: Chloroquine

chloroquine plus prednisone

prednisone DRUG

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

azathioprine plus prednisone; chloroquine plus prednisone

azathioprine DRUG

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

azathioprine plus prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Discrete biochemical changes and histological inflammatory activity absent / minimal (periportal / peri-septal: 0/1 +) or decompensated cirrhosis
• Cases of loss of follow up

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (1)

• 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.

  PMID: 32514439 DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

chloroquine diphosphate; Chloroquine; Prednisone; Azathioprine

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Lydia Teófilo de Moraes Falcão
• Organization: Clinic Hospital of University of Sao Paulo

lydiatmf@yahoo.com.br

55-81-996486935

Study Officials

• Eduardo LR Cançado

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis: a Randomized Trial

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2003
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2016
• Last Updated: February 15, 2017
• Results First Posted: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share