The International ITP Registry

October 26, 2016 updated by: South Eastern Sydney Local Health District

A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. Individual hospitals only encounter a small number of ITP patients each year which makes it difficult to study this disease. By creating this disease registry, we will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries. Research of this kind will help future patients by providing doctors with information about ITP, and about how patients have been treated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is an observational disease registry database for recently-diagnosed adult patients with primary ITP that aims to understand the natural history of this rare disease and disease management. Participating investigators will prospectively enter real-world patient data on their enrolled patients with a minimum of 2 years follow up.

Data from this registry will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and adverse outcomes (resulting from treatment or disease) on ITP patients on an annual basis. The information will be generated at the national or combined-country level. Furthermore, each institution will have an access to its data and may choose to generate descriptive statistics for its specific institution on a more frequent, ad-hoc basis. New research questions or questions addressing a subset of registry patients to take advantage of combined registry data will require a separate protocol and review by independent committees

The focus of this protocol is on adults with primary ITP, however, in future there may be interest to expand the population to explore secondary ITP patients as well. Hence, this registry is built to allow for some optional preliminary information related to secondary ITP to be captured.

Multi-site participation of this registry project will be rolled out in stages, and will be offered to centres with appropriate expertise. Pilot countries included Australia, Korea, Taiwan, Singapore, Malaysia, Japan, Thailand and Turkey and sites will be selected based on their potential research (interest, resources, and expected patient volume). Additional sites may be added in the future from countries in Asia Pacific, Middle East and Latin America. Japan has an independent national ITP registry run by the government, however voluntary participation of interested Japanese investigators in this database will be welcomed, therefore allowing comparison of data between Japanese and non-Japanese patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Recruiting
        • Canberra Hospital
        • Contact:
          • Philip Crispin
    • New South Wales
      • Sydney, New South Wales, Australia
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
          • Tim Brighton
      • Sydney, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Contact:
          • Beng H Chong
          • Phone Number: +612 9113 3246
        • Contact:
          • Sarah Davidson
          • Phone Number: +612 9113 2446
        • Principal Investigator:
          • Beng H Chong
      • Sydney, New South Wales, Australia
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Michael Harvey
      • Sydney, New South Wales, Australia
        • Recruiting
        • Calvary Mater Newcastle
        • Contact:
          • Michelle Gambrill
      • Sydney, New South Wales, Australia
        • Recruiting
        • Concord Hospital
        • Contact:
          • Ilona Cunningham
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Simon McRae
      • Adelaide, South Australia, Australia
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Douglas Coghlan
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hang Quach
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred
        • Contact:
          • Huyen Tran
  • Colombia
      • Busaramanga, Colombia
        • Recruiting
        • FOSCAL
        • Contact:
          • Luis SALAZAR
      • Colombia, Colombia
        • Recruiting
        • Hemato-Oncologos
        • Contact:
          • Rigoberto GOMEZ
      • Colombia, Colombia
        • Recruiting
        • Hospital Pablo Tobón Uribe
        • Contact:
          • Kenny Galvez
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Ji-hyeon KWON
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jin Seok KIM
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Centre
        • Contact:
          • Je-Hwan LEE
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St Mary's Hospital
        • Contact:
          • Jong Wook LEE
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Centre
        • Contact:
          • Jun Ho JANG
  • Kuwait
      • Kuwait City, Kuwait
        • Completed
        • Mubarak Alkabeer Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Active, not recruiting
        • Ampang Hospital
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Subang Jaya Medical Centre
        • Contact:
          • Soo Chin NG
      • Penang, Malaysia
        • Active, not recruiting
        • Penang Hospital
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
        • Contact:
          • Dr Liu
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Lai Heng LEE
  • Taiwan
      • TAiwan, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Li Yaun BAI
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veteran's General Hospital
        • Contact:
          • Tzeon-Jye Chiou
      • Taiwan, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
          • Yi-Fang Chang
      • Taiwan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Tsai-Yun CHEN
      • Taiwean, Taiwan
        • Recruiting
        • Taichung Veteran's General Hospital
        • Contact:
          • Wen Li HWANG
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Siriraj Hospital
        • Contact:
          • Yinyong CHINTHAMMITR
      • Bangkok, Thailand
        • Recruiting
        • Ramathibodi Hospital
        • Contact:
          • Pantep ANGCHAISUKSIRI
      • Chiang Mai, Thailand
        • Recruiting
        • Chiang Mai University
        • Contact:
          • Weerasak NAWARAWONG
      • Thailand, Thailand
        • Recruiting
        • Chulalongkorn University
        • Contact:
          • Pollapat ROJNUCKARIN
      • Thailand, Thailand
        • Recruiting
        • Pramongkutlao College of MEdicine
        • Contact:
          • Tontanai NUMBENJAPON
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara University
        • Contact:
          • Osman Ilhan
      • Ankara, Turkey
        • Recruiting
        • Ankara Numune Training and Research Hosptial
        • Contact:
          • Funda CERAN
      • Ankara, Turkey
        • Recruiting
        • Ankara Oncology Training and Research Hospital
        • Contact:
          • Fevzi Altuntas
      • PAmukkale, Turkey
        • Recruiting
        • Pamukkale University Medical Faculty
        • Contact:
          • Hakan Ismail SARI
      • Turkey, Turkey
        • Recruiting
        • Dokuz Eylul University Medical Faculty
        • Contact:
          • Mehmet Ali OZCAN
      • Turkey, Turkey
        • Recruiting
        • Erciyes University Medical Faculty
        • Contact:
          • Ali UNAL
      • Turkey, Turkey
        • Recruiting
        • Gaziantep University Medical Faculty
        • Contact:
          • Vahap OKAN
  • Uruguay
      • Uruguay, Uruguay
        • Recruiting
        • CASMU
        • Contact:
          • Lina Foren
      • Uruguay, Uruguay
        • Recruiting
        • Hospital Britanico
        • Contact:
          • Silvia Pierri
      • Uruguay, Uruguay
        • Recruiting
        • Hospital Militar
        • Contact:
          • Maria Virginia COSTA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults recently-diagnosed with primary ITP will be prospectively enrolled into the registry. In cases where prospective data collection is not possible from initial diagnosis, eg if sites see mainly referred patients, those patients with pre-existing ITP of no longer than 6 months duration since diagnosis will be allowed into the registry, provided they are still prospectively being followed up or under ongoing review / treatment at the participating institution.

Description

Inclusion Criteria:

  1. Recently-diagnosed (i.e. < 6 months) primary ITP adults patients (≥ 18 years) characterized by platelet counts less than 100x109/L as defined by the International Working Group1.
  2. Able to provide written consent for data to be included in the registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Primary Immune Thrombocytopaenia
Recently-diagnosed (i.e. < 6 months) primary ITP adult patients (≥ 18 years) characterized by platelet counts less than 100x109/L as defined by the International Working Group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease progression of ITP
Time Frame: up to 24 months
This will include response assessment to each treatment modality, incidence and characteristics of bleeding events, bone marrow results (if available), 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 Group.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Eastern Sydney Local Health District

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Beng H Chong, SESLHD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTBR-017 (TRA114972)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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