|
Main
|
|
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. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000021407 |
|
Date of registration:
|
15/03/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A study of efficacy and safety of 5-aminolevulinic acid phosphate in patients with sideroblastic anemia
|
|
Scientific title:
|
A study of efficacy and safety of 5-aminolevulinic acid phosphate in patients with sideroblastic anemia - Efficacy and safety of 5-ALA phosphate in patients with sideroblastic anemia |
|
Date of first enrolment:
|
2016/03/15 |
|
Target sample size:
|
5 |
|
Recruitment status: |
Complete: follow-up continuing |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022716 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Hiroshi
Kawabata |
|
Address:
|
54 Shogo-in Kawaharacho, Sakyo-ku, Kyoto
606-8507
Japan |
|
Telephone:
|
075-751-4964 |
|
Email:
|
hkawabat@kuhp.kyoto-u.ac.jp |
|
Affiliation:
|
Graduate School of Medicine, Kyoto University Department of Hematology and Oncology |
|
|
Name:
|
Akifumi
Takaori-Kondo |
|
Address:
|
54 Shogo-in Kawaharacho, Sakyo-ku, Kyoto
Japan |
|
Telephone:
|
075-751-3150 |
|
Email:
|
atakaori@kuhp.kyoto-u.ac.jp |
|
Affiliation:
|
Graduate School of Medicine, Kyoto University Department of Hematology and Oncology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Platelet count less than 100,000/micro L. Neutrophil count less than 1500/micro L.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
sideroblastic anemia
|
|
Intervention(s)
|
|
Orally intake a 150 mg 5-aminolevulinic acid phosphate capsule once a day for up to 24 weeks.
|
|
Primary Outcome(s)
|
|
Efficacy (improvement of the hemoglobin value) at 12 weeks after the initiation of the treatment.
|
|
Secondary Outcome(s)
|
|
Safety until 8 weeks after the discontinuation of the treatment.
|
|
Source(s) of Monetary Support
|
|
Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University
|
|
Ethics review
|
Status: YES
Approval date: 26/02/2016
Contact:
ethcom@kuhp.kyoto-u.ac.jp
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
|
|