The International ITP Registry
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| ClinicalTrials.gov Identifier: NCT01970189 |
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Recruitment Status : Unknown
Verified July 2016 by South Eastern Sydney Local Health District.
Recruitment status was: Recruiting
First Posted : October 28, 2013
Last Update Posted : October 27, 2016
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| Condition or disease |
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| Thrombocytopenia |
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 : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| 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 |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | December 2016 |
| Estimated Study Completion Date : | December 2020 |
| Group/Cohort |
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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.
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- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
- Able to provide written consent for data to be included in the registry
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
| 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
| Study Chair: | Beng H Chong | SESLHD |
| Responsible Party: | South Eastern Sydney Local Health District |
| ClinicalTrials.gov Identifier: | NCT01970189 |
| Other Study ID Numbers: |
CTBR-017 (TRA114972) |
| First Posted: | October 28, 2013 Key Record Dates |
| Last Update Posted: | October 27, 2016 |
| Last Verified: | July 2016 |
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Immune Thrombocytopenia Primary Immune Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenia Thrombocytopenia |
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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 |