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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.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000012478
Date of registration: 01/01/2014
Prospective Registration: Yes
Primary sponsor: Department of Internal Medicine, Teikyo University School of Medicine
Public title: Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus
Scientific title: Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus
Date of first enrolment: 2014/04/01
Target sample size: 10
Recruitment status: Recruiting
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014604
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Hajime    Kono
Address:  Kaga 2-11-1, Itabashi-ku, Tyoko173-8605 173-8605 Japan
Telephone: 03-3964-1211
Email: kono@med.teikyo-u.ac.jp
Affiliation:  Department of Internal Medicine, Teikyo University School of Medicine Rheumatology and Allergy
Name: Hajime    Kono
Address:  Kaga 2-11-1, Itabashi-ku, Tyoko173-8605 Japan
Telephone: 03-3964-1211
Email: kono@med.teikyo-u.ac.jp
Affiliation:  Department of Internal Medicine, Teikyo University School of Medicine Rheumatology and Allergy
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: Patients with severe insufficiency in liver, kidney, heart, bone marrow function. Patients with current or previous history of retinopathy. Patients allergic to 4-aminoquinoline. Other patients who were judged to be ineligible for the study by an attending physician.

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
systemic lupus erythematosus cutaneous lupus erythematosus
Intervention(s)
Treatment with Hydroxychloroquine
Primary Outcome(s)
CLASI score
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 31/03/2014
Contact:
turb-office@teikyo-u.ac.jp
Teikyo University Ethics Committee
03-3964-1211
turb-office@teikyo-u.ac.jp
Results
Results available: Yes
Date Posted:
Date Completed: 31/03/2023
URL:
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