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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01443351
• Other study ID #: TPO-SJ-227
• Status: Withdrawn
• Start date: March 2015
• Est. completion date: August 2019

Study information

• Verified date: September 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Roskilde	Roskilde

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with sustained response at 6 months follow-up	Response is defined as platelet count > 30.000 mio/L and no bleeding	6 months
Secondary	Yearly response rates	Number of patients with response to treatment at 1, 2, 3, 4, and 5-year follow-up	5 years
Secondary	Frequency of relapse		5 years
Secondary	Rate of splenectomy		5 years
Secondary	Development of reticulin fibrosis in bone marrow biopsies		5 years