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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017093
Receipt No. 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 2018/10/11

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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
Middle name
Last name Toshikatsu Kaburaki
Organization University of Tokyo Graduate School of Medicine
Division name Opthalmology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku Tokyo 113-0033, Japan
TEL 03-3815-5411
Email kabutosi-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutomi Mizuuchi
Organization Hokkaido University Graduate School of Medicine
Division name Department of Opthalmology
Zip code
Address Kita-15,Nishi-7,Kita-ku,Sapporo 060-9638,Japan
TEL 011-706-5944
Homepage URL
Email mizuuchi@peach.plala.or.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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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