UMIN-CTR Clinical Trial

Public title

A prospective registration for newly diagnosed adults with primary immune thrombocytopenia (ITP) in Japan.

Acronym

ITP-Registry in Japan

Scientific Title

A prospective registration for newly diagnosed adults with primary immune thrombocytopenia (ITP) in Japan.

Scientific Title:Acronym

ITP-Registry in Japan

Region

Japan

Condition

Immune Thrombocytopenia (ITP)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compile an anonymous centralised database of demographic, ITP-specific, and co-morbid disease information on newly diagnosed Japanese adults with ITP.

Basic objectives2

Others

Basic objectives -Others

1. To estimate the prevalence of morbidity at baseline and incidence of newly occurring events and morbidities during the follow-up phase of the registry.

2. To document local treatment practices and medications used for adult patients with ITP across multiple regions and countries in collaboration with other registries.

3. To explore a prognostic model for developing major bleeding or other complications among adult patients with ITP.

4. To identify factors that predict life-threatening bleeding as well as identify factors that predict requirement of early treatment.

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The disease course of ITP will be observed. This will include response assessment to each treatment modality, progression to refractory ITP, and the efficacy of any medical intervention (whether beneficial or detrimental) according to the overall severity of the disease, according to definitions described by the ITP International Working Group.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Recently-diagnosed (i.e. < 6 months) primary ITP adults patients (> 18 years) with platelet counts less than 100x109/L as defined by the International Working Group.
This means that diagnosis of ITP should be within 6 months prior to enrolment into the registry.
2. Able to provide written consent for data to be included in the registry

Key exclusion criteria

Not Applicable

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Shinichiro Okamoto

Organization

Keio University School of Medicine

Division name

Division of Hematology Department of Internal Medicine

Zip code

Address

35 Shinanomachi Shinjuku Tokyo

TEL

03-3353-1211(ext.61335)

Email

okamoto@a7.keio.jp

Name of contact person

1st name
Middle name
Last name	Clinical and Translational Research Center

Organization

Keio University Hospital

Division name

Clinical and Translational Research Center

Zip code

Address

#111, Clinical Research Building, 35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3523

Homepage URL

Email

dm-group@ctr.hosp.keio.ac.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Novartis Pharma K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、岩手医科大学附属病院（岩手県）、済生会中央病院（東京都）、東海大学附属八王子病院（東京都）、北海道大学病院（北海道）、金沢大学附属病院（石川県）、永寿総合病院（東京都）、立川病院（東京都）

Date of disclosure of the study information

2014

Year

04

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

11

Month

21

Day

Date of IRB

2012

Year

03

Month

26

Day

Anticipated trial start date

2014

Year

05

Month

01

Day

Last follow-up date

2020

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Outcome definition and measures
The disease progression of ITP will be observed. This will include response assessment to each treatment modality, development of refractory ITP and effects of any medical intervention (whether beneficial or detrimental) in the overall severity of the disease, according to definitions described by the ITP International Working Group1.

Exposure definition and measures
Not applicable

Covariate definition and measures
a) Country, institution and investigator details
b) Patient demographics
c) Key dates:
d) Diagnostic laboratory investigations as recommended by International Consensus Report
e) Laboratory investigations for follow-up visits
f) Co-morbidities (yes/no, date) of interest
g) Bleeding events (with dates)
h) Any blood products support utilized for the bleeding events
i) Any interventional procedures (with dates) instituted for the management of ITP
j) Any pharmacotherapeutic agents administered

Registered date

2014

Year

04

Month

30

Day

Last modified on

2021

Year

05

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016091