- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820960
Risk Factors for Thrombosis in Immune Thrombocytopenia (RiFT-ITP)
Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease…). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.
Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Toulouse, France
- University Hospital TOULOUSE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Incident primary ITP adults
Exclusion Criteria:
- Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk for thrombosis in adult primary ITP patients treated with ITP treatment
Time Frame: from July 2009 until June 2015
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Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment
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from July 2009 until June 2015
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk thrombosis in adult primary ITP patients treated with TPO-RAs.
Time Frame: from July 2009 until June 2015
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Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.
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from July 2009 until June 2015
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume Moulis, MD, University Hospital, Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Embolism and Thrombosis
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Thrombosis
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- RC31/17/0148
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immune Thrombocytopenia
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Institute of Hematology & Blood Diseases Hospital...Henan Cancer Hospital; Beijing Children's Hospital; Tianjin Medical University... and other collaboratorsRecruitingPrimary Immune Thrombocytopenia (ITP)China
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argenxWithdrawnPrimary Immune Thrombocytopenia (ITP)
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Novartis PharmaceuticalsRecruitingPrimary Immune Thrombocytopenia (ITP)China, United States, Spain, Singapore, Austria, Germany, Belgium, Italy, Japan, Czechia, Hong Kong, Hungary, Malaysia, Argentina, Bulgaria, Turkey, Vietnam, Australia, Thailand, Mexico, United Kingdom, France, Romania, Norway, India
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European Research Consortium on ITPFondazione Progetto EmatologiaCompletedPrimary Immune Thrombocytopenia (ITP)Spain, Switzerland, United Kingdom, Italy, France, Norway
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University Children's Hospital BaselNovartis Pharmaceuticals; Stiftung zur Förderung medizinischer und biologischer... and other collaboratorsActive, not recruiting
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Gruppo Italiano Malattie EMatologiche dell'AdultoCompletedAdult Patients | Immune Primary Thrombocytopenia | Splenectomy | TPO-mimeticsItaly
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National Heart, Lung, and Blood Institute (NHLBI)RecruitingImmune Mediated Anemia | Immune Mediated Thrombocytopenia | Chronic GVHDUnited States
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National Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationImmune Mediated Anemia | Immune Mediated Thrombocytopenia | Chronic GVHDUnited States
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Changzhou No.2 People's HospitalRui Therapeutics Co., LtdNot yet recruitingThrombocytopenia Alloimmune
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Nahda UniversityRecruiting