Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

December 2, 2022

Primary Completion Date

October 24, 2026

Study Completion Date

October 24, 2026

Conditions
Primary Immune Thrombocytopenia
Interventions
DRUG

romiplostim plus dexamethasone

Patients will be reviewed weekly for 8 weeks (56 days). After Week 8, patients will be reviewed every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.

DRUG

Dexamethasone

Patients will be reviewed weekly until the completion of dexamethasone cycles and for a minimum of 8 weeks (56 days). After that, every 2 weeks (14 days) for 8 additional weeks and then monthly until Week 52 (365 days) from randomization.

Trial Locations (30)

3008

Hospital Universitario Morales Meseguer, Murcia

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

18014

Hospital Universitario Virgen de las Nieves, Granada

28007

Hospital General Universitario Gregorio Marañón, Madrid

28046

Compejo Hospitalario La Paz, Madrid

28922

Hospital Universitario Fundación Alcorcon, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

30120

Hospital Clínico Universitario Virgen de la Arrixaca, Murcia

37007

Complejo Asistencial Universitario de Salamanca, Salamanca

41013

Hospital Universitario Virgen del Rocío, Seville

46026

Hospital Universitario y Pilitécnico La Fe, Valencia

Unknown

IRCCS AOU di Bologna, Seràgnoli Institute of Hematology, Bologna

ASST Fatebenefratelli Sacco - Ospedale L. Sacco, Milan

Grande Ospedale Metropolitano Niguarda, Milan

Azienda Ospedaliero-Universitaria Policlinico Umberto I / SAPIENZA Universitá di Roma, Rome

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Rome

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

University Hospitals Birmingham NHS Foundation Trust, Birmingham

University Hospitals Bristol and Weston NHS Trust, Bristol

Haemophilia and Thrombosis Centre, Kent & Canterbury Hospital, Kent & Canterbury Hospital, Ethelbert Road, Canterbury, CT1 3NG, England, UK, Canterbury

Greater Glasgow and Clyde Health Board, London

Haematology, Royal Victoria Infirmary, Newcastle

Norfolk & Norwich University Hospital Trust, Norwich

Oxford University Hospitals NHS Foundation Trust, Oxford

"Haematology, Derriford Hospital, University Hospitals Plymouth NHS Trust", Plymouth

Torbay and South Devon NHS Foundation Trust, Torquay

08003

Hospital del Mar, Barcelona

08035

Centre Sociosanitari Sant Jordi de la Vall D'Hebron, Barcelona

09006

Complejo Asistencial Universitario de Burgos, Burgos

07120

Complejo Asistencial Son Espases, Palma de Mallorca

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER