Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Zealand University Hospital

Status: Withdrawn

Conditions: Idiopathic Thrombocytopenic Purpura

Study type: Observational

Funder types: Other

Identifiers

NCT01443351

TPO-SJ-227

Details and patient eligibility

About

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 these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

0 participants in 1 patient group

ITP patients

Description:

Patients with refractory ITP eligible for treatment with TPO-ra