NCT01980745

Brief Summary

Autoimmune hepatitis is an autoimmune chronic liver disease whose treatment includes the use of immunosuppressive drugs, particularly azathioprine, and corticosteroids. When properly treated, patients have a good survival. One of the major problems related to its treatment is the the high rate of relapses after stopping therapy that has lead to biochemical and histological remissions, close to 80%. Many authors recommend continuous treatment throughout life, resulting in the occurrence of many side effects. Chloroquine is a drug with anti-inflammatory properties already used in the treatment of other extrahepatic autoimmune liver diseases. There are some reports in the literature about its beneficial use in liver diseases such as chronic hepatitis B, and a pilot study in patients with autoimmune hepatitis, in which its use was associated with a 6.49 times lower risk of disease recurrence when compared with patients in whom treatment was discontinued after remission. Our purpose is to investigate, in a double-blind randomized trial with placebo, whether chloroquine prevents the recurrence of AIH in patients with histological remission after discontinuation of conventional treatment and to evaluate the occurrence of side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

11.8 years

First QC Date

September 24, 2013

Last Update Submit

October 25, 2016

Conditions

Hepatitis, Autoimmune

Keywords

autoimmune hepatitisrecurrencetreatment withdrawalchloroquinemaintenance of remission

Outcome Measures

Primary Outcomes (1)

  • Recurrence of autoimune hepatitis after treatment withdrawal in patients maintained only with chloroquine

    To evaluate the rate of recurrence of autoimmune hepatitis with histological remission after withdrawal of corticosteroids and immunosuppressive drugs and after introduction of maintenance therapy with chloroquine or placebo. Recurrence is defined by the sustained increase or progressive liver enzymes above twice the upper normal reference value (as defined by the criteria of the International Autoimmune Hepatitis) in at least two different dosages taken with an interval of 15 to 30 days.

    thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine

Secondary Outcomes (2)

  • Side effects of chloroquine

    thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine

  • Side effects of chloroquine

    thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine

Study Arms (2)

Chloroquine diphosphate

ACTIVE COMPARATOR

chloroquine diphosphate 250mg/day

Drug: Chloroquine diphosphate 250mg

sugar pill

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

Chloroquine diphosphate 250mgDRUG

Sugar pill (placebo) one pill per day for 1110 days Chloroquine diphosphate 250mg per day for 1110 days

Chloroquine diphosphate
PlaceboDRUG
sugar pill

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histological remission during treatment with immunosuppressive drugs (Liver biopsy with periportal inflammatory activity less than 2)
  • 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:

  • patients who needed to suspend the drug under six months of the medication because of side effects or the patient's desire
  • cases of loss of follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo School of Medicine

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • Mucenic M, Mello ES, Cancado EL. Chloroquine for the maintenance of remission of autoimmune hepatitis: results of a pilot study. Arq Gastroenterol. 2005 Oct-Dec;42(4):249-55. doi: 10.1590/s0004-28032005000400011. Epub 2006 Jan 19.

    PMID: 16444381BACKGROUND

MeSH Terms

Conditions

Hepatitis, AutoimmuneRecurrence

Interventions

chloroquine diphosphate

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Débora R Terrabuio, master

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 24, 2013

First Posted

November 11, 2013

Study Start

February 1, 2002

Primary Completion

November 1, 2013

Study Completion

June 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

BR(1)