UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056465 |
|---|---|
| Receipt number | R000064525 |
| Scientific Title | The specified surveillance of romiplostim, a study of long-term use in aplastic anemia patients who are refractory to conventional therapies (all-case surveillance). |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2024/12/16 11:47:36 |
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Basic information
Public title
The specified surveillance of romiplostim, a study of long-term use in aplastic anemia patients who are refractory to conventional therapies (all-case surveillance).
Acronym
The specified surveillance of romiplostim
Scientific Title
The specified surveillance of romiplostim, a study of long-term use in aplastic anemia patients who are refractory to conventional therapies (all-case surveillance).
Scientific Title:Acronym
The specified surveillance of romiplostim
Region
| Japan |
Condition
Condition
aplastic anemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the occurrence of bleeding, thromboembolism, myelofibrosis, and hematologic malignancies in aplastic anemia patients who are refractory to conventional therapies under the clinical use of Romiplostim.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Safety
(1) Bleeding
(2) Thromboembolism
(3) Myelofibrosis
(4) Hematologic malignancies
2.Efficacy
(1) Change in platelets
(2) Change in Hb levels
(3) Change in neutrophils
Key secondary outcomes
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
Aplastic anemia patients who are refractory to conventional therapies.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
hiroshi.kuwazawa.wd@kyowakirin.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
hiroshi.kuwazawa.wd@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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
| 2024 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
It is not available for the public.
Publication of results
Unpublished
Result
URL related to results and publications
It is not available for the public.
Number of participants that the trial has enrolled
535
Results
Of 490 patients in Safety Analysis Set, drug-related adverse events were reported in 17.55%. The most common events were Platelet count increased (1.22%) and Headache (1.02%). A total of 322 patients could be followed up for up to 2-year after the initiation of treatment. No adverse events relevant to Myelofibrosis were observed in these patients. Regarding events relevant to Hematological Malignancies, 17 patients experienced adverse events.
Results date posted
| 2024 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The proportion of gender was 43.06% for male and 56.94% for female. The mean (SD) of age was 66.35 (16.87) years. 64.69% of the patients were 65 years or older. The proportion of severity of aplastic anemia was 39.39% for Non-Severe, 40.82% for Severe, and 19.59% for Very Severe.
Participant flow
After the contract is signed with the hospital, the physician will fill out the required information on the registration form and send the form for registration via fax.
Adverse events
Of 490 patients in Safety Analysis Set, adverse events were reported in 56.53%. The main events were febrile neutropenia (7.14%), aplastic anemia (6.33%), and pneumonia (3.67%). The proportion of serious adverse events reported was 33.88%.
Outcome measures
Incidence of drug-related adverse events and infections, Examination of safety specifications, Transition of platelet counts, and Matters concerning patients with special backgrounds: pediatric, elderly, pregnant and nursing women, and patients with renal and liver dysfunction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064525
