drugset / Trial / NCT07700238

A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)

NCT07700238

Phase 3 Not yet recruiting 126 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).

Timeline

Start
2026-07-20
Primary completion
2029-09-14
Completion
2029-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified Oral
Subject Romiplostim Peptide Subcutaneous