UMIN-CTR Clinical Trial

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
Email	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
Email	k.hase59@med.hokudai.ac.jp

Sponsor
Institute	University of Tokyo Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019823