UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044014 |
|---|---|
| Receipt number | R000050130 |
| Scientific Title | Long term follow-up observational study after clinical trials of AMG531 (Romiplostim) in patients with untreated Aplastic Anemia (531-005 Study) |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2024/10/25 10:01:22 |
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Basic information
Public title
Long term follow-up observational study after clinical trials of AMG531 (Romiplostim) in patients with untreated Aplastic Anemia (531-005 Study)
Acronym
531-005
Scientific Title
Long term follow-up observational study after clinical trials of AMG531 (Romiplostim) in patients with untreated Aplastic Anemia (531-005 Study)
Scientific Title:Acronym
531-005
Region
| Japan | Asia(except Japan) |
Condition
Condition
aplastic anemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation [up to 5 years] of patients who were registered for study 531-003/531-004 in immunosuppressive therapy-naive patients with aplastic anemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of hematological response at 2 years and up to 5 years after the start of romiplostim treatment in study 531-003/531-004
Key secondary outcomes
1) Duration of hematological response in patients who achieved hematologic response at the completion of study 531-003/531-004
2) Time courses of Hb level, platelet count, and neutrophil count
3) Presence or absence of platelet/red blood cell transfusion and G-CSF product administration
4) Dose level and administration period of cyclosporine A
5) Presence or absence of transformation to MDS/AML and presence or absence of occurrence of new chromosome abnormality
6) Time to the start of subsequent treatment or to death
7) Overall survival
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
Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out
Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system
Key exclusion criteria
Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Yamazaki |
Organization
Kanazawa University Hospital
Division name
Blood Transfusion Department
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa Ishikawa
TEL
076-265-2000
ma.oncology.g.19@kyowakirin.com
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Gamou |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
ma.oncology.g.19@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13-1 Takara-machi, Kanazawa Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 22 | 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
36
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
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Long term follow-up (up to 5 years) observation of patients who were registered for study 531-003/531-004 in immunosuppressive therapy-naive patients with aplastic anemia.
Management information
Registered date
| 2021 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050130
