RecruitingPhase 3NCT07700238

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

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).


Sponsor

Amgen

Enrollment

126 participants

Start Date

Aug 21, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Predniso(lo)ne and a drug called Romiplostim for people with primary immune thrombocytopenia. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRomiplostim

Administered subcutaneously.

DRUGPredniso(lo)ne

Administered orally.


Locations(3)

MemorialCare Long Beach Medical Center

Long Beach, California, United States

The Bleeding and Clotting Disorders Institute

Peoria, Illinois, United States

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07700238


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