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)
NCT number | NCT01443351 |
Other study ID # | TPO-SJ-227 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | August 2019 |
Verified date | September 2019 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital Roskilde | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital | Odense University Hospital, Rigshospitalet, Denmark |
Denmark,
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 |
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