UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016580 |
|---|---|
| Receipt number | R000019237 |
| Scientific Title | Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies |
| Date of disclosure of the study information | 2015/02/19 |
| Last modified on | 2018/01/02 11:37:26 |
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Basic information
Public title
Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies
Acronym
Sirolimus for vascular anomalies
Scientific Title
Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies
Scientific Title:Acronym
Sirolimus for vascular anomalies
Region
| Japan |
Condition
Condition
Lymphangiomatosis, Gorham-Stout disease and vascular anomalies
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Hematology and clinical oncology |
| Surgery in general | Chest surgery | Pediatrics |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of sirolimus for lymphangiomatosis, Gorham-Stout disease and vascular anomalies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of clinical symptoms at 1, 3, 6, 12 after administration
Key secondary outcomes
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
Oral sirolimus
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
| 0 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with intaracbtable lymphangiomatosis, Gorham-Stout disease and vascular anomalies
Key exclusion criteria
Allergy of sirolimus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Ozeki |
Organization
Gifu University
Division name
Pediatrics
Zip code
Address
1-1, Yanagito, Gifu-shi, Gifu
TEL
058-230-6000
michioo@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Ozeki |
Organization
Gifu University
Division name
Pediatrics
Zip code
Address
1-1, Yanagito, Gifu-shi, Gifu
TEL
058-230-6000
Homepage URL
michioo@gifu-u.ac.jp
Sponsor or person
Institute
Gifu university
Institute
Department
Personal name
Funding Source
Organization
Gifu university
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
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
| 2015 | Year | 02 | Month | 19 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 19 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019237
