ThrombocytopeniaNCT01970189
The International ITP Registry
An observational study of Thrombocytopenia, run by South Eastern Sydney Local Health District at 44 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- How many people
- 500 participants
- Where
- 44 sitesin 10 countries
- Study dates
- Jan 2011to Dec 2020
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
44 sites in 10 countries.
44 sites in 10 countries
Australia10 sites, 10 recruiting
- Recruiting
Flinders Medical Centre
Adelaide, South Australia
Douglas Coghlan
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
Simon McRae
- Recruiting
Canberra Hospital
Canberra, Australian Capital Territory
Philip Crispin
- Recruiting
St Vincent's Hospital
Melbourne, Victoria
Hang Quach
- Recruiting
The Alfred
Melbourne, Victoria
Huyen Tran
- Recruiting
St George Hospital
Sydney, New South Wales, 2217
Beng H Chong, +612 9113 3246
Sarah Davidson, +612 9113 2446
- Recruiting
Calvary Mater Newcastle
Sydney, New South Wales
Michelle Gambrill
- Recruiting
Concord Hospital
Sydney, New South Wales
Ilona Cunningham
- Recruiting
Liverpool Hospital
Sydney, New South Wales
Michael Harvey
- Recruiting
Prince of Wales Hospital
Sydney, New South Wales
Tim Brighton
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Ankara Numune Training and Research Hosptial
Ankara
Funda CERAN
- Recruiting
Ankara Oncology Training and Research Hospital
Ankara
Fevzi Altuntas
- Recruiting
Ankara University
Ankara
Osman ILHAN
- Recruiting
Pamukkale University Medical Faculty
Pamukkale
Hakan Ismail SARI
- Recruiting
Dokuz Eylul University Medical Faculty
Turkey
Mehmet Ali OZCAN
- Recruiting
Erciyes University Medical Faculty
Turkey
Ali UNAL
- Recruiting
Gaziantep University Medical Faculty
Turkey
Vahap OKAN
South Korea5 sites, 5 recruiting
- Recruiting
ASAN Medical Centre
Seoul
Je-Hwan LEE
- Recruiting
Samsung Medical Centre
Seoul
Jun Ho JANG
- Recruiting
Seoul National University Hospital
Seoul
Ji-hyeon KWON
- Recruiting
Seoul St Mary's Hospital
Seoul
Jong Wook LEE
- Recruiting
Severance Hospital
Seoul
Jin Seok KIM
Taiwan5 sites, 5 recruiting
- Recruiting
China Medical University Hospital
Dawan
Li Yaun BAI
- Recruiting
Mackay Memorial Hospital
Dawan
Yi-Fang CHANG
- Recruiting
National Cheng Kung University Hospital
Dawan
Tsai-Yun CHEN
- Recruiting
Taipei Veteran's General Hospital
Taipei
Tzeon-Jye Chiou
- Recruiting
Taichung Veteran's General Hospital
Taiwean
Wen Li HWANG
Thailand5 sites, 5 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok
Pantep ANGCHAISUKSIRI
- Recruiting
Siriraj Hospital
Bangkok
Yinyong CHINTHAMMITR
- Recruiting
Chiang Mai University
Chiang Mai
Weerasak NAWARAWONG
- Recruiting
Chulalongkorn University
Thailand
Pollapat ROJNUCKARIN
- Recruiting
Pramongkutlao College of MEdicine
Thailand
Tontanai NUMBENJAPON
Colombia3 sites, 3 recruiting
- Recruiting
Foscal
Busaramanga
Luis SALAZAR
- Recruiting
Hemato-Oncologos
Colombia
Rigoberto GOMEZ
- Recruiting
Hospital Pablo Tobón Uribe
Colombia
Kenny Galvez
Malaysia3 sites, 1 recruiting
- Active, not recruiting
Penang Hospital
George Town
- Active, not recruiting
Ampang Hospital
Kuala Lumpur
- Recruiting
Subang Jaya Medical Centre
Kuala Lumpur
Soo Chin NG
Uruguay3 sites, 3 recruiting
- Recruiting
CASMU
Uruguay
Lina Foren
- Recruiting
Hospital Britanico
Uruguay
Silvia Pierri
- Recruiting
Hospital Militar
Uruguay
Maria Virginia COSTA
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Dr Liu
- Recruiting
Singapore General Hospital
Singapore
Lai Heng LEE
About this study
Official title: 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.
Read the 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.
- Conditions
- Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenia, Thrombocytopenia
- Medical subject headings
- Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- South Eastern Sydney Local Health District
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Beng H Chong, Study chair, SESLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970189
- Sponsor's protocol ID
- CTBR-017 (TRA114972)
- Status last verified
- Jul 2016
- First submitted
- 19 Sep 2013
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries
- ClinicalTrials.gov ID
- NCT01970189
- Acronym / sponsor ID
- CTBR-017 (TRA114972)
- Conditions
- Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Purpura, Thrombocytopenic, Idiopathic, Autoimmune Thrombocytopenia, Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- South Eastern Sydney Local Health DistrictOther government
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beng H Chong study chair
SESLHD
44 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by South Eastern Sydney Local Health District at 44 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Australia, Turkey (Türkiye), South Korea, Taiwan, Thailand and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beng H Chong, Professor (+612 91133426, benghock.chong@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression of ITP (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.