UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000052251
Receipt number	R000059645
Scientific Title	G-Lasta (pegfilgrastim) Subcutaneous Injection 3.6 mg General use-results survey (all-case survey) -Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation-
Date of disclosure of the study information	2023/09/20
Last modified on	2023/09/20 09:50:04

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Basic information

Public title

G-Lasta (pegfilgrastim) Subcutaneous Injection 3.6 mg
General use-results survey (all-case survey)
-Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation-

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

All donors who have received pegfilgrastim for the first time after the date of approval of the indication "Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation"

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The objective of this survey was to confirm the safety of pegfilgrastim in real-world clinical practice when administered to healthy donors for Mobilization and collection of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation, and to determine the sufficiency of the collected hematopoietic stem cells for transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Safety
-Incidence of adverse reactions
-Incidence of adverse drug reactions and infectious diseases
-Examination of Safety specifications
-Examination of other adverse events (headache, liver dysfunction, etc.)
-Safety after peripheral blood stem cells collection
-Factors that may affect safety

Key secondary outcomes

Efficacy
-Securing the number of peripheral blood stem cells required for transplantation
-Factors that may influence the evaluation of efficacy

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

All donors who have received pegfilgrastim for the first time after the date of approval of the indication " Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation "

Key exclusion criteria

-The contract with the facility has not been concluded
-Outside the contract period with the facility
-Peripheral blood stem cell collection using a daily G-CSF other than pegfilgrastim*
*Registration is possible if peripheral blood stem cell collection was performed
using a daily G-CSF other than pegfilgrastim in the past.
-This is not the first time to collect peripheral blood stem cells by administration
of pegfilgrastim
-Duplicate registration (already registered)

Target sample size

350

Research contact person

Name of lead principal investigator

1st name Takanori

Middle name

Last name Teshima

Organization

Hokkaido University Hospital

Division name

Department of Hematology

Zip code

060-8648

Address

Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo

TEL

+81-11-706-5639

Email

teshima@med.hokudai.ac.jp

Public contact

Name of contact person

1st name Hiroshi

Middle name

Last name Kuwazawa

Organization

Kyowa Kirin Co., Ltd.

Division name

Kyowa Kirin Co., Ltd.

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

+81-70-3143-9628

Homepage URL

Email

hiroshi.kuwazawa.wd@kyowakirin.com

Sponsor or person

Institute

Other

Institute

Department

Personal name

Funding Source

Organization

Other

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

Research Ethical Review Committee of Kyowa Kirin Co., Ltd.

Address

1-9-2, Otemachi, Chiyoda-ku, Tokyo, Japan

Tel

03-5205-7202

Email

researchethics.fj@kyowakirin.com

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 Year 09 Month 20 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

Open public recruiting

Date of protocol fixation

2022 Year 02 Month 21 Day

Date of IRB

2023 Year 08 Month 17 Day

Anticipated trial start date

2022 Year 02 Month 25 Day

Last follow-up date

2026 Year 02 Month 24 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This survey is general use results survey (All Cases Survey) based on the ministerial ordinance on implementation of Good Post-marketing Study Practice.

Management information

Registered date

2023 Year 09 Month 20 Day

Last modified on

2023 Year 09 Month 20 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059645