UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049715 |
|---|---|
| Receipt number | R000056629 |
| Scientific Title | In-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2022/12/07 15:13:02 |
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Basic information
Public title
In-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Acronym
In-house platelet transfusion
Scientific Title
In-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Scientific Title:Acronym
In-house platelet transfusion
Region
| Japan |
Condition
Condition
Hematologic disorders
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a method of attenuation of antibody titer by in-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Titer of donor-specific antibodies
Key secondary outcomes
engraftment
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
| Other |
Interventions/Control_1
in-house platelet transfusion
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with hematopoietic diseases who are refractory to chemotherapy and for whom allogeneic hematopoietic stem cell transplantation is the only curative option
Key exclusion criteria
Case that sufficient stem cells cannot be harvested from the donor
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Arai |
Organization
St. Marianna University School of Medicine
Division name
St. Marianna University School of Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL
044-977-8111
ara.hema@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Arai |
Organization
St. Marianna University School of Medicine
Division name
Division of Hematology & Oncology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL
044-977-8111
Homepage URL
ara.hema@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics review board, St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japa
Tel
044-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 08 | 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
| 2022 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056629
| 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 |
