Clinical Trial

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

Study acronym: RODEX
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-04-08; most recent amendment 2025-06-12.
Status change: Recruiting → Active, Not Recruiting 2025-06-12
Status change: Not Yet Recruiting → Recruiting 2022-12-22
Trial Details
NCT Number NCT05325593
Lead Sponsor Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions Primary Immune Thrombocytopenia
Enrollment 129 participants
Start Date 2022-12-02
Primary Completion 2026-10-24 (estimated)
Study Completion 2026-10-24 (estimated)
Updated on ClinicalTrials.gov 2025-06-17