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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013102
Receipt No. R000015284
Scientific Title Efficacy of Zoledronate for RAS associated ALPS like disease (RALD)
Date of disclosure of the study information 2014/03/01
Last modified on 2017/10/12

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Basic information
Public title Efficacy of Zoledronate for RAS associated ALPS like disease (RALD)
Acronym Zoledronate for RALD
Scientific Title Efficacy of Zoledronate for RAS associated ALPS like disease (RALD)
Scientific Title:Acronym Zoledronate for RALD
Region
Japan

Condition
Condition RAS associated ALPS like disease (RALD)
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of efficacy of zoledronate for RALD
Basic objectives2 Others
Basic objectives -Others Reduction of immunosuppressive agents including steroid
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Alleviation of autoimmunity
Key secondary outcomes Reduction of immunosuppressive agents including steroid

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intravenous drip infusion of Zoledronate
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) RAS associated ALPS like disease
2) Performance Status 0-2
3) CTCAE < Grade I
4) Written informed consent is obtained from gurdian in case of children
Key exclusion criteria 1) Pregnant women and during breast feeding.
2) Uncontrollable infection
3) Serious complication such as heart, kidney and liver failure.
4) Malignancy (except for juvenile myelomonocytic leukemia)
5) Dental disease need to be treated.
6) One who is not suitable by doctor's decision..
7) One who attended other clinical study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Takagi
Organization Tokyo Medical and Dental Univeristy
Division name Pediatrics
Zip code
Address Yushima1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5249
Email m.takagi.ped@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Takagi
Organization Tokyo Medical and Dental Univeristy
Division name Pediatrics
Zip code
Address Yushima1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5249
Homepage URL
Email m.takagi.ped@tmd.ac.jp

Sponsor
Institute Department of Pediatrics, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization MHLW The Specified Disease Treatment Research Program
Organization
Division
Category of Funding Organization Japanese Governmental office
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 東京医科歯科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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 Terminated
Date of protocol fixation
2013 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 10 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
2014 Year 02 Month 07 Day
Last modified on
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015284

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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