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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01970189




Registration number
NCT01970189
Ethics application status
Date submitted
19/09/2013
Date registered
28/10/2013
Date last updated
27/10/2016

Titles & IDs
Public title
The International ITP Registry
Scientific title
A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries
Secondary ID [1] 0 0
CTBR-017 (TRA114972)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombocytopenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease progression of ITP
Timepoint [1] 0 0
up to 24 months

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Sydney
Recruitment hospital [4] 0 0
Concord Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [7] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [10] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Busaramanga
Country [2] 0 0
Colombia
State/province [2] 0 0
Colombia
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Kuwait
State/province [4] 0 0
Kuwait City
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kuala Lumpur
Country [6] 0 0
Malaysia
State/province [6] 0 0
Penang
Country [7] 0 0
Singapore
State/province [7] 0 0
Singapore
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taipei
Country [9] 0 0
Taiwan
State/province [9] 0 0
TAiwan
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taiwan
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taiwean
Country [12] 0 0
Thailand
State/province [12] 0 0
Bangkok
Country [13] 0 0
Thailand
State/province [13] 0 0
Chiang Mai
Country [14] 0 0
Thailand
State/province [14] 0 0
Thailand
Country [15] 0 0
Turkey
State/province [15] 0 0
Ankara
Country [16] 0 0
Turkey
State/province [16] 0 0
PAmukkale
Country [17] 0 0
Turkey
State/province [17] 0 0
Turkey
Country [18] 0 0
Uruguay
State/province [18] 0 0
Uruguay

Funding & Sponsors
Primary sponsor type
Other
Name
South Eastern Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01970189
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Beng H Chong
Address 0 0
SESLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Beng H Chong, Professor
Address 0 0
Country 0 0
Phone 0 0
+612 91133426
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01970189