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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT01980745 |
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Date of registration:
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24/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS
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Scientific title:
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DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITIS |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01980745 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Débora R Terrabuio, master |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria: - diagnosis of autoimmune hepatitis according to Autoimmune Hepatitis
International Group
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis, Autoimmune
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Intervention(s)
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Drug: Chloroquine diphosphate 250mg
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Drug: Placebo
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Primary Outcome(s)
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Recurrence of autoimune hepatitis after treatment withdrawal in patients maintained only with chloroquine
[Time Frame: thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine]
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Secondary Outcome(s)
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Side effects of chloroquine
[Time Frame: thirty-six months after immunosuppressive treatment withdrawal and initial use of chloroquine]
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Secondary ID(s)
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0697/07
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CAPPesq 0697/07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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