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The International ITP Registry

This study is currently recruiting participants.
Verified July 2016 by South Eastern Sydney Local Health District
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970189
First Posted: October 28, 2013
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
South Eastern Sydney Local Health District
  Purpose
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.

Condition
Thrombocytopenia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries

Resource links provided by NLM:


Further study details as provided by South Eastern Sydney Local Health District:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970189


Contacts
Contact: Beng H Chong, Professor +612 91133426 benghock.chong@health.nsw.gov.au
Contact: Sarah Davidson, BNurs +612 9113 2446 sarah.davidson1@health.nsw.gov.au

  Show 44 Study Locations
Sponsors and Collaborators
South Eastern Sydney Local Health District
GlaxoSmithKline
Investigators
Study Chair: Beng H Chong SESLHD
  More Information

Responsible Party: South Eastern Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01970189     History of Changes
Other Study ID Numbers: CTBR-017 (TRA114972)
First Submitted: September 19, 2013
First Posted: October 28, 2013
Last Update Posted: October 27, 2016
Last Verified: July 2016

Keywords provided by South Eastern Sydney Local Health District:
Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenia
Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms