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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009370
Receipt No. R000011015
Scientific Title Thalidomide therapy clinical trial for chronic granulomatous disease-associated intractable granulomatous lesion
Date of disclosure of the study information 2012/11/21
Last modified on 2017/05/25

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Basic information
Public title Thalidomide therapy clinical trial for chronic granulomatous disease-associated intractable granulomatous lesion
Acronym Thalidomide therapy for chronic granulomatous disease
Scientific Title Thalidomide therapy clinical trial for chronic granulomatous disease-associated intractable granulomatous lesion
Scientific Title:Acronym Thalidomide therapy for chronic granulomatous disease
Region
Japan

Condition
Condition Chronic granulomatous disease
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Patients with chronic granulomatous disease-associated intractable granulomatous lesion are treated with thalidomide therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cure or mitigation of granulomatous lesion
Key secondary outcomes An effect on susceptibility to infection

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of thalidomide
Interventions/Control_2
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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria chronic granulomatous disease
intractable granulomatous lesion
Key exclusion criteria a pregnant woman
positive for HIV
severe allegy
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOSHINAO KAWAI
Organization National Center for Child Heath and Development
Division name Department of Human Genetics
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Email kawai-t@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinao Kawai
Organization National Center for Child Heath and Development
Division name Department of Human Genetics
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Homepage URL
Email kawai-t@ncchd.go.jp

Sponsor
Institute National Center for Child Heath and Development
Institute
Department

Funding Source
Organization Grant of MHLW
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2012 Year 11 Month 21 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
2012 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 07 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 04 Month 30 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 20 Day
Last modified on
2017 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011015

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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