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NOT YET RECRUITING
NCT07700238
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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).

Official title: A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2026-07-20

Completion Date

2029-09-14

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DRUG

Romiplostim

Administered subcutaneously.

DRUG

Predniso(lo)ne

Administered orally.