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

Primary Immune Thrombocytopenia Clinical Trial

Official title:
A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

Clinical Trial Summary

Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia

Clinical Trial Description

The main objective of the study is to evaluate the superiority of romiplostim plus dexamethasone versus dexamethasone alone in the treatment of primary immune thrombocytopenia, with sustained response to any ITP treatment and without World Health Organization grade 2 or higher bleeding, after six months from cessation of treatment. Maximum time on treatment with romiplostim will be 12 months (365 days). Then, patients will be followed up for 6 additional months (180 days) after stopping romiplostim. Clinical rules are included if romiplostim dose should be modified or finished. In case of dexamethasone, no dose adjustment is permitted. The evaluation of romiplastim plus dexamethasone´s superiority in different periods and platelet count, proportion of patients with complete response (CR), global response (GR), early response (ER) and initial response (IR); time to loss of response (LoR), adverse events, quality of life and healthcare resources use are included as secondary objectives. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05325593
Study type Interventional
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Clara M Rosso Fernández, MD-PhD
Phone +34955013414
Email claram.rosso.sspa@juntadeandalucia.es
Status Recruiting
Phase Phase 3
Start date December 2, 2022
Completion date September 30, 2026
View Details
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