Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

Last updated: April 28, 2025
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Completed

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Thrombocytopenia And Thrombocytopenia Prevention

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

Eltrombopag

Romiplostin

Clinical Study ID

NCT02298075
ITP0714
  • Ages > 18
  • All Genders

Study 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 failed one or more therapy lines, splenectomy included.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 therapyafter failure of one or more therapy lines, splenectomy included;

  • Age > 18 years.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Eltrombopag
Phase:
Study Start date:
April 01, 2016
Estimated Completion Date:
April 17, 2019

Study 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' series. At this time, systematic data collections on this topic do not exist and the real incidence of such persistent response is unknown. Therefore, because of the increasing interest in this new and challenging therapeutic field, also for the therapeutic implications, we would like to investigate the impact of TPO- RAs on the achievement of sustained and persistent responses after their discontinuation in the Italian adult patients affected by pITP who have been referred to the GIMEMA Centers.

Connect with a study center

  • S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti

    Asti,
    Italy

    Site Not Available

  • Istituto di Ematologia "Lorenzo e A. Seragnoli"

    Bologna,
    Italy

    Site Not Available

  • Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi

    Catania,
    Italy

    Site Not Available

  • Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano

    Firenze,
    Italy

    Site Not Available

  • Clinica Medica III - Padiglione ex isolamento - Azienda Ospedale Università San Martino

    Genova,
    Italy

    Site Not Available

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce,
    Italy

    Site Not Available

  • Azienda Ospedaliera "S.Gerardo"

    Monza,
    Italy

    Site Not Available

  • Ematologia - Ospedale San Carlo

    Potenza,
    Italy

    Site Not Available

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia,
    Italy

    Site Not Available

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma,
    Italy

    Site Not Available

  • U.O.C. Ematologia - Ospedale S. Eugenio

    Rome,
    Italy

    Site Not Available

  • Università degli studi "Sapienza" di Roma

    Rome,
    Italy

    Site Not Available

  • Ematologia - Dipartimento di Medicina Clinica e Sperimentale

    Sassari,
    Italy

    Site Not Available

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