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 2022/08/03 09:48:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

ma.oncology.g.19@kyowakirin.com


Public contact

Name of contact person

1st name Mami
Middle name
Last name Shimizu

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


Email

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

Email

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


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

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

2022 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name