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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013855
Receipt No. R000016091
Scientific Title A prospective registration for newly diagnosed adults with primary immune thrombocytopenia (ITP) in Japan.
Date of disclosure of the study information 2014/04/30
Last modified on 2021/05/06

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Basic information
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
Condition Immune Thrombocytopenia (ITP)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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
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

Research contact person
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

Public contact
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

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Novartis Pharma K.K.
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
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 30 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 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
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

Management information
Registered date
2014 Year 04 Month 30 Day
Last modified on
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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