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

September 9, 2019 updated by: Sif Gudbrandsdottir, Zealand University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Copenhagen University Hospital Roskilde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patinets will be selected from Departments of Hematology

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ITP patients
Patients with refractory ITP eligible for treatment with TPO-ra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with sustained response at 6 months follow-up
Time Frame: 6 months
Response is defined as platelet count > 30.000 mio/L and no bleeding
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yearly response rates
Time Frame: 5 years
Number of patients with response to treatment at 1, 2, 3, 4, and 5-year follow-up
5 years
Frequency of relapse
Time Frame: 5 years
5 years
Rate of splenectomy
Time Frame: 5 years
5 years
Development of reticulin fibrosis in bone marrow biopsies
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Odense University Hospital
Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hans Hasselbalch, Prof., MD, Department of Hematology, Copenhagen University Hospital Roskilde
  • Principal Investigator: Henrik Frederiksen, Dr., MD, Odense University Hospital
  • Principal Investigator: Sif Gudbrandsdottir, MD, Copenhagen University Hospital Roskilde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPO-SJ-227

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.

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