NCT01970189

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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
10 countries

44 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 27, 2016

Status Verified

July 1, 2016

Enrollment Period

5.9 years

First QC Date

September 19, 2013

Last Update Submit

October 26, 2016

Conditions

Keywords

Immune ThrombocytopeniaPrimary Immune ThrombocytopeniaPurpura, Thrombocytopenic, IdiopathicAutoimmune ThrombocytopeniaThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Calvary Mater Newcastle

Sydney, New South Wales, Australia

RECRUITING

Concord Hospital

Sydney, New South Wales, Australia

RECRUITING

Liverpool Hospital

Sydney, New South Wales, Australia

RECRUITING

Prince of Wales Hospital

Sydney, New South Wales, Australia

RECRUITING

Flinders Medical Centre

Adelaide, South Australia, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

St Vincent's Hospital

Melbourne, Victoria, Australia

RECRUITING

The Alfred

Melbourne, Victoria, Australia

RECRUITING

Foscal

Busaramanga, Colombia

RECRUITING

Hemato-Oncologos

Colombia, Colombia

RECRUITING

Hospital Pablo Tobón Uribe

Colombia, Colombia

RECRUITING

Mubarak Alkabeer Hospital

Kuwait City, Kuwait

COMPLETED

Penang Hospital

George Town, Malaysia

ACTIVE NOT RECRUITING

Ampang Hospital

Kuala Lumpur, Malaysia

ACTIVE NOT RECRUITING

Subang Jaya Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

National University Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

ASAN Medical Centre

Seoul, South Korea

RECRUITING

Samsung Medical Centre

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St Mary's Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

China Medical University Hospital

Dawan, Taiwan

RECRUITING

Mackay Memorial Hospital

Dawan, Taiwan

RECRUITING

National Cheng Kung University Hospital

Dawan, Taiwan

RECRUITING

Taipei Veteran's General Hospital

Taipei, Taiwan

RECRUITING

Taichung Veteran's General Hospital

Taiwean, Taiwan

RECRUITING

Ramathibodi Hospital

Bangkok, Thailand

RECRUITING

Siriraj Hospital

Bangkok, Thailand

RECRUITING

Chiang Mai University

Chiang Mai, Thailand

RECRUITING

Chulalongkorn University

Thailand, Thailand

RECRUITING

Pramongkutlao College of MEdicine

Thailand, Thailand

RECRUITING

Ankara Numune Training and Research Hosptial

Ankara, Turkey (Türkiye)

RECRUITING

Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

Pamukkale University Medical Faculty

Pamukkale, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University Medical Faculty

Turkey, Turkey (Türkiye)

RECRUITING

Erciyes University Medical Faculty

Turkey, Turkey (Türkiye)

RECRUITING

Gaziantep University Medical Faculty

Turkey, Turkey (Türkiye)

RECRUITING

CASMU

Uruguay, Uruguay

RECRUITING

Hospital Britanico

Uruguay, Uruguay

RECRUITING

Hospital Militar

Uruguay, Uruguay

RECRUITING

MeSH Terms

Conditions

ThrombocytopeniaPurpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaPurpura, ThrombocytopenicPurpuraBlood Coagulation DisordersThrombotic MicroangiopathiesHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Beng H Chong

    SESLHD

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

October 28, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2020

Last Updated

October 27, 2016

Record last verified: 2016-07

Locations