UMIN-CTR Clinical Trial

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
Email	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
Email	michioo@gifu-u.ac.jp

Sponsor
Institute	Gifu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033354