UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014041
Receipt number R000016285
Scientific Title The combination therapy of prednisolone and cyclosporine for initial onset of Vogt-Koyanagi-Harada disease.
Date of disclosure of the study information 2014/05/22
Last modified on 2017/11/23 12:54:43

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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

Individual

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 Ryoji Yanai

Organization

Yamaguchi University Hospital

Division name

Opthalmology

Zip code


Address

1-1-1 Minami Kogushi,Ube-city,Yamaguchi,Japan

TEL

0836-22-2278

Email

sonodak@yamaguchi-u.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 or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University Hospital

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



Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 22 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

2018 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

2014 Year 05 Month 22 Day

Last modified on

2017 Year 11 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name