NCT02063763

Brief Summary

This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 14, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2015

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

February 13, 2014

Last Update Submit

October 12, 2020

Conditions

Adult PatientsImmune Primary ThrombocytopeniaSplenectomyTPO-mimetics

Keywords

Adult patientsImmune primary thrombocytopeniaSplenectomyTPO-mimeticsEltrombopagRomiplostim

Outcome Measures

Primary Outcomes (1)

  • Number of patients responding to TPO-mimetics

    According to platelet count and presence or absence of hemorrhagic events.

    Six months.

Secondary Outcomes (4)

  • Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy.

    Six months.

  • Frequency and ways of administration.

    Six months

  • Number of hemorrhagic events.

    At thirty days from splenectomy.

  • Frequency of toxicity.

    Six months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.

You may qualify if:

  • Persistent or chronic ITP in symtomatic phase.
  • years of age or older.
  • Indication for splenectomy due to refractory response to a previous therapy.
  • Have used eltrombopag or romiplostim to increase platelet count before splenectomy.
  • Have undergone splenectomy.

You may not qualify if:

  • No informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

U.O.C di Ematologia P.O. "S.Giuseppe Moscati"

Aversa, Italy

Location

UOC Ematologia Ospedale " Mons. Dimiccoli"

Barletta, Italy

Location

Policlinico di Careggi

Florence, Italy

Location

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

Lecce, Italy

Location

Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana

Lido di Camaiore, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

Milan, Italy

Location

Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano

Milan, Italy

Location

Unità Trapianto di Midollo Ist. Nazionale Tumori

Milan, Italy

Location

Azienda Ospedaliera "S.Gerardo"

Monza, Italy

Location

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

Location

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, Italy

Location

A.O. Santa Maria - Terni S.C Oncoematologia

Terni, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

Location

Related Links

Study Officials

  • Francesco Zaja, Pr.

    Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

May 14, 2014

Primary Completion

February 26, 2015

Study Completion

February 26, 2015

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(14)