UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029175 |
|---|---|
| Receipt number | R000033354 |
| Scientific Title | The pharmacokinetic analysis and safety of sirolimus treatment for pediatric patients with intractable vascular anomalies |
| Date of disclosure of the study information | 2017/09/17 |
| Last modified on | 2021/03/21 16:33:44 |
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Basic information
Public title
The pharmacokinetic analysis and safety of sirolimus treatment for pediatric patients with intractable vascular anomalies
Acronym
The pharmacokinetic analysis of sirolimus for pediatric patients with intractable vascular anomalies
Scientific Title
The pharmacokinetic analysis and safety of sirolimus treatment for pediatric patients with intractable vascular anomalies
Scientific Title:Acronym
The pharmacokinetic analysis of sirolimus for pediatric patients with intractable vascular anomalies
Region
| Japan |
Condition
Condition
Intractable vascular anomalies
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Neurology | Surgery in general |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Radiology | Oral surgery |
| Neurosurgery | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetic analysis and safety of sirolimus treatment for the Japanese pediatric patients
Basic objectives2
Others
Basic objectives -Others
To research the association between the trough levels of sirolimus and adverse effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pharmacokinetic analysis of sirolimus treatment for the Japanese pediatric patients
Key secondary outcomes
The safety of sirolimus treatment for the Japanese pediatric patients
The association between the trough levels of sirolimus and adverse effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The patients with intractable vascular anomalies who are going to treat with sirolimus
Key exclusion criteria
1. Patients with a history of hypersensitivity to ingredients of this drug
2. Patients with serious liver and renal disorders
3. Patients with symptoms that affect cytokine value of such obvious infection at the time of specimen collection
4. Patients must also avoid strong inducers of CYP3A4
5. Past usage of mTOR inhibitors or other molecular target drugs relating mTOR pathway
6. Patient who is judged inappropriate to participate in this study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Ozeki |
Organization
Gifu University Hospital
Division name
The department of Pediatrics
Zip code
503-0015
Address
1-1 Yanagito, Gifu-shi, Gifu-ken
TEL
058-230-6000
michioo@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Ozeki |
Organization
Gifu University Hospital
Division name
The department of Pediatrics
Zip code
503-0015
Address
1-1 Yanagito, Gifu-shi, Gifu-ken
TEL
058-230-6000
Homepage URL
michioo@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1 yanagito gifu
Tel
058-230-6000
rinri@gifu-u.ac.jp
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
岐阜薬科大学（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 17 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For more information, please contact the Principal Investigator.
Management information
Registered date
| 2017 | Year | 09 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
