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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Thrombocytopenic Purpura

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ITP patients

Patients with refractory ITP eligible for treatment with TPO-ra

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No