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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016401 |
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Date of registration:
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10/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
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Scientific title:
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Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation - Tranilast in preventing GVHD after allogeneic HSCT |
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Date of first enrolment:
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2015/02/10 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019049 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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TAKEHIKO
MORI |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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tmori@a3.keio.jp |
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Affiliation:
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Keio University School of Medicine Division of Hematology |
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Name:
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Takehiko
MORI |
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Address:
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35Shinanomachi, Shinjuku-ku,
1608582
Japan |
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Telephone:
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0333531211 |
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Email:
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tmori@a3.keio.jp |
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Affiliation:
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Keio University School of Medicine Division of Hematology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Poorly controlled diabetes even with insulin treatment 2) Poorly controlled hypertension 3) Poorly controlled active infection 4) Not expecting 3 months or longer survival due to refractory disease or infection 5) Requring immediate tapering of immunosuppressant because of high risk of disease replapse 6) Active disease infiltration of central nervous system 7) Active double cancer 8) Pregnant or nursing patients 9) Poorly controlled psychiatric disorder 10) History of hypersensitivity or moderate or greater adverse events due to tranilast, cyclosporine, tacrolimus, and methotrexate.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Paients aged 20 years or greater who undergo allogeneic hematopoietic stem cell transplatation from an unrelated donor
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Intervention(s)
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Administration of tranilast to hematopoietic stem cell transplant recipients
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Primary Outcome(s)
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Non-hematological adverse events within 28 days after transplantation
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Source(s) of Monetary Support
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Health and Labor Sciences Research Grant
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Ethics review
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Status: YES
Approval date: 26/01/2015
Contact:
med-rinri-jimu@adst.keio.ac.jp
Ethical Committe of Keio University School of Medicine
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/12/2018 |
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URL:
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