UMIN ID: UMIN000013373
Registered date:01/04/2014
The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi- Harada disease.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Vogt-Koyanagi- Harada disease |
Date of first enrollment | 2014/04/01 |
Target sample size | 120 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 1.The group given only prednisolone mPSL 1000mg Intravenous Infusion 3 days PSL 0.6~0.7 mg/kg Oral Administration 10 days PSL 0.5~0.6 mg/kg Oral Administration 10 days PSL 0.4~0.5 mg/kg Oral Administration 10 days PSL 0.3~0.4 mg/kg Oral Administration 4 weeks PSL 0.2~0.3 mg/kg Oral Administration 4 weeks PSL 0.1~0.2 mg/kg Oral Administration 4 weeks PSL 0.05~0.1 mg/kg Oral Administration 8 weeks PSL 0.05~0.1 mg/kg every other day Oral Administration 4 weeks 2.The group given combination of prednisolone and cyclosporine In addition to "1.", CYA 3mg/kg is administered from day 4 |
Outcome(s)
Primary Outcome | Proportion of subjects showing recurrences of uveitis with VKH disease |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 70years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1.Renal dysfunction 2.Immunosuppressant treatment including steroid 3.Immunocompromised condition 4.Females who are pregnant or lactating patients or who are suspicious of pregnant 5.Malignant neoplasm 6.Intraocular surgery (except for cataract surgery) or glaucoma surgery previously, or speculate to be required in the periods of this study 7.Investigator declare a subject ineligible for any sound reasons |
Related Information
Primary Sponsor | Hokkaido University Graduate School of Medicine |
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Secondary Sponsor | Kyushu University Graduate School of Medicine National Defense Medical College Hospital Kagoshima University Graduate School of Medicine Kyorin University Hospital Yamaguchi University Hospital Kanazawa University Hospital Graduate School of Medicine, The University of Tokyo Kochi Medical School Hospital Kobe University Hospital |
Source(s) of Monetary Support | Hokkaido University Graduate School of Medicine |
Secondary ID(s) |
Contact
public contact | |
Name | Kazuomi Mizuuchi |
Address | Kita-15, Nishi-7, Kita-ku, Sapporo 060-8638, Japan Japan |
Telephone | 011-706-5944 |
mizuuchi@peach.plala.or.jp | |
Affiliation | Hokkaido University Graduate School of Medicine Department of Ophthalmology |
scientific contact | |
Name | Kenichi Namba |
Address | Kita-15, Nishi-7, Kita-ku, Sapporo 060-8638, Japan Japan |
Telephone | 011-706-5944 |
knamba@med.hokudai.ac.jp | |
Affiliation | Hokkaido University Graduate School of Medicine Department of Ophthalmology |