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NCT01970189

The International ITP Registry

NCT ID: NCT01970189

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thrombocytopenia

Keywords

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Immune Thrombocytopenia Primary Immune Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenia Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beng H Chong

Role: STUDY_CHAIR

SESLHD

Locations

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