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

NCT01443351 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-09-11

No results posted yet for this study

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 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.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Hans Hasselbalch, Prof., MD · Department of Hematology, Copenhagen University Hospital Roskilde

  • Henrik Frederiksen, Dr., MD · Odense University Hospital

  • Sif Gudbrandsdottir, MD · Copenhagen University Hospital Roskilde

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443351 on ClinicalTrials.gov