Status:
COMPLETED
Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who...
Detailed Description
Increasing evidence exists in the literature on the persistent response after TPO-RAs discontinuation. However, the available data consist of description of case reports from different patients' serie...
Eligibility Criteria
Inclusion
- Signed written informed consent according to ICH/EU/GCP and national local laws;
- Persistent or chronic pITP adult patients who have been treated with TPO-RAs therapy after failure of one or more therapy lines, splenectomy included;
- Age \> 18 years.
Exclusion
- Active malignancy;
- Active malignancy;
- HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
- Chronic liver disease;
- Treatment with Rituximab less than 8 weeks before TPO-RAs start;
- Recent splenectomy (less than 8 weeks) before TPO-RAs start. Active malignancy;
- HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
- Chronic liver disease;
- Treatment with Rituximab less than 8 weeks before TPO-RAs start;
- Recent splenectomy (less than 8 weeks) before TPO-RAs start. HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
- Chronic liver disease;
- Treatment with Rituximab less than 8 weeks before TPO-RAs start;
- Recent splenectomy (less than 8 weeks) before TPO-RAs start.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT02298075
Start Date
April 1 2016
End Date
April 17 2019
Last Update
April 29 2025
Active Locations (13)
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1
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
Asti, Italy
2
Istituto di Ematologia "Lorenzo e A. Seragnoli"
Bologna, Italy
3
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
Catania, Italy
4
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence, Italy