UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017093 |
|---|---|
| Receipt number | R000019823 |
| Scientific Title | The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease. |
| Date of disclosure of the study information | 2015/04/10 |
| Last modified on | 2020/04/27 13:47:55 |
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Basic information
Public title
The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease.
Acronym
PSL/CYA combination therapy for VKH disease
Scientific Title
The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease.
Scientific Title:Acronym
PSL/CYA combination therapy for VKH disease
Region
| Japan |
Condition
Condition
Vogt-Koyanagi-Harada disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of subjects showing recurrences of uveitis with VKH disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.The group given only prednisolone
mPSL 1000mg Intravenous Infusion 3 days
PSL 0.6-0.7mg/kg Oral Administrarion 10 days
PSL 0.5-0.6mg/kg Oral Administrarion 10 days
PSL 0.4-0.5mg/kg Oral Administrarion 10 days
PSL 0.3-0.4mg/kg Oral Administrarion 4 weeks
PSL 0.2-0.3mg/kg Oral Administrarion 4 weeks
PSL 0.1-0.2mg/kg Oral Administrarion 4 weeks
PSL 0.05-0.1mg/kg Oral Administrarion 8 weeks
PSL 0.05-0.1mg/kg every other day Oral Administrarion 4 weeks
Interventions/Control_2
2.The group given combination of prednisolone and cyclosporine
In addition to "1.",CYA 3mg/kg is administered from day 4
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients of initial onset VKH disease who present all of a) to d)
a)Within 4 weeks from disease onset
b)Showing anterior chamber cells maximum 2+
c)Without sunset glow fundus
2.Complete or incomplete type of VKH disease
3.Showing cerebrospinal fluid pleocytosis or meningeal irritation signs except headache alone
4.Who can recieve the treatment within 4 weeks from the disease onset
Key exclusion 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.Ontraocular 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
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Tanaka |
Organization
University of Tokyo Graduate School of Medicine
Division name
Opthalmology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku Tokyo 113-8655, Japan
TEL
03-3815-5411
rtanaka-ymn@umin.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Hase |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Opthalmology
Zip code
060-8648
Address
Kita-15,Nishi-7,Kita-ku,Sapporo 060-8648,Japan
TEL
011-706-5944
Homepage URL
k.hase59@med.hokudai.ac.jp
Sponsor or person
Institute
University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Graduate School of Medicine and Faculty of Medicine at The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 09 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019823
