Status:
WITHDRAWN
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Odense University Hospital
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Brief Summary
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of th...
Eligibility Criteria
Inclusion
- Adult patients with ITP
- platelet counts \< 25 x10\*9/L or \< 50 x10\*9/L with bleeding symptoms
- meets criteria for treatment with TPO-ra
- Females must use contraceptives when applicable for at least three months before inclusion
Exclusion
- Pregnancy or nursing
- Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation
- Liver insufficiency (for eltrombopag only)
- TPO-ra contraindications (e.g. allergy)
- TPO-ra treatments less than 6 months prior to inclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01443351
Start Date
March 1 2015
End Date
August 1 2019
Last Update
September 11 2019
Active Locations (1)
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1
Copenhagen University Hospital Roskilde
Roskilde, Denmark, 4000