The International ITP Registry

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01970189
• Other study ID #: CTBR-017 (TRA114972)
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2013
• Last updated: October 26, 2016
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: July 2016
• Source: South Eastern Sydney Local Health District
• Contact: Beng H Chong, Professor
• Phone: +612 91133426
• Email: benghock.chong[@]health.nsw.gov.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeColombia: Institutional Review BoardMalaysia: Institutional Review BoardMalaysia: Ministry of HealthSingapore: Institutional Review BoardSouth Korea: Institutional Review BoardTaiwan: Institutional Review BoardThailand: Ethical CommitteeTurkey: Ethics CommitteeTurkey: Ministry of HealthUruguay: Comite de EticaUruguay: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	The Alfred	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Sydney	New South Wales
Australia	Concord Hospital	Sydney	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Colombia	Foscal	Busaramanga
Colombia	Hemato-Oncologos	Colombia
Colombia	Hospital Pablo Tobón Uribe	Colombia
Korea, Republic of	ASAN Medical Centre	Seoul
Korea, Republic of	Samsung Medical Centre	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Kuwait	Mubarak Alkabeer Hospital	Kuwait City
Malaysia	Ampang Hospital	Kuala Lumpur
Malaysia	Subang Jaya Medical Centre	Kuala Lumpur
Malaysia	Penang Hospital	Penang
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Taiwan	Taipei Veteran's General Hospital	Taipei
Taiwan	China Medical University Hospital	TAiwan
Taiwan	Mackay Memorial Hospital	Taiwan
Taiwan	National Cheng Kung University Hospital	Taiwan
Taiwan	Taichung Veteran's General Hospital	Taiwean
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Chiang Mai University	Chiang Mai
Thailand	Chulalongkorn University	Thailand
Thailand	Pramongkutlao College of MEdicine	Thailand
Turkey	Ankara Numune Training and Research Hosptial	Ankara
Turkey	Ankara Oncology Training and Research Hospital	Ankara
Turkey	Ankara University	Ankara
Turkey	Pamukkale University Medical Faculty	PAmukkale
Turkey	Dokuz Eylul University Medical Faculty	Turkey
Turkey	Erciyes University Medical Faculty	Turkey
Turkey	Gaziantep University Medical Faculty	Turkey
Uruguay	CASMU	Uruguay
Uruguay	Hospital Britanico	Uruguay
Uruguay	Hospital Militar	Uruguay

Sponsors (2)

Lead Sponsor	Collaborator
South Eastern Sydney Local Health District	GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Colombia,  Korea, Republic of,  Kuwait,  Malaysia,  Singapore,  Taiwan,  Thailand,  Turkey,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression of ITP	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	No