UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023437 |
|---|---|
| Receipt number | R000027002 |
| Scientific Title | Clinical study of combination local injection sclerotherapy of bleomycin and OK-432 for intractable lymphatic malformations |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2019/08/04 12:56:42 |
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Basic information
Public title
Clinical study of combination local injection sclerotherapy of bleomycin and OK-432 for intractable lymphatic malformations
Acronym
Study of combination sclerotherapy of bleomycin and OK-432 for LMs
Scientific Title
Clinical study of combination local injection sclerotherapy of bleomycin and OK-432 for intractable lymphatic malformations
Scientific Title:Acronym
Study of combination sclerotherapy of bleomycin and OK-432 for LMs
Region
| Japan |
Condition
Condition
Lymphangioma and other lymphatic diseases with similar lesion
Classification by specialty
| Surgery in general | Vascular surgery | Pediatrics |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Oral surgery | Plastic surgery | Aesthetic surgery |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of combination local injection sclerotherapy of bleomycin and OK-432
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The proportion of subjects that the volume of therapeutic target area in the lesion is reduced 30% or more
Key secondary outcomes
Appearance, degree of uplift due to lesions, clinical symptoms such as lymph leakage and bleeding, pain, and frequency of fever / redness,the subjects' impression of their improvement and their degree of satisfaction. Changes in the lung shadows on chest X-ray.
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
"OK-432 and bleomycin slolution" (0.05 kE / mL and 0.5 mg / mL, respectively) will be injected into the lesion with water-soluble contrast agent.
Maximum dose of bleomycin is 10 mg / dose and 5 mg/kgBW.
Cumulative maximum dose in repeated treatment is 10 mg/kgBW.
OK-432 concentration might be redued to the range from 0.01 to 0.05 kE / mL by the attending physician's judgment, for reasons such as reducing the inflammation induced by OK-432.
[Exit criteria]
When subjects and family members reach satisfaction with the level of reduction of the lesion.
When the cumulative dose reaches the maximum dose.
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
Patients requiring treatment in the National Center for Child Health and Development, diagnosed as lymphangioma (lymphatic malformation, common and cystic lymphatic malformation) or other lymphatic disease with similar pathological tissue.
Among the above-mentioned subject, patients satisfying the following conditions A and B, and having understood and agreed to the research by document, will be included.
Condition A; satisfying the following condition a or b.
a; spongy lesions remaining after the OK-432 therapy in the past
b; spongy lesion untreated with sclerotherapy and expected of no efficacy of OK-432
Condition B; surgical resection is difficult to apply.
Key exclusion criteria
Patients with any of the following diseases will be excluded.
Severe lung dysfunction, lung fibrosis lesions and significant lung lesions, history of hypersensitivity to bleomycin hydrochloride and similar compounds to the (peplomycin), severe renal dysfunction, severe heart disease, and history of radiation to the chest and the periphery
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujino |
Organization
National Center for Child Health and Development
Division name
Division of Pediatric Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-Ku, Tokyo 157-8535
TEL
03-3416-0181
fujino-a@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujino |
Organization
National Center for Child Health and Development
Division name
Division of Pediatric Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-Ku, Tokyo 157-8535
TEL
03-3416-0181
Homepage URL
fujino-a@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Tokyo
Tel
03-3416-0181
rinken@ncchd.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180265
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | 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
29
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027002
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/08/08 | BLM for LM 研究計画書改訂5.1版20210408.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/02/01 | BLM for LM CRF ver2.0.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/02/01 | BLM for LM CRF ver2.0.xlsx |
