UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009370 |
|---|---|
| Receipt number | 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 11:36:14 |
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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
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
kawai-t@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Heath and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011015
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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