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126 Participants NeededMy employer runs this trial

Romiplostim + Prednisone for Thrombocytopenic Purpura

(ROMISTER Trial)

Recruiting at 2 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with primary immune thrombocytopenia (ITP) who have not received any prior treatment for it and need therapy. Participants must have a low platelet count and cannot have had emergency ITP treatments or spleen removal.

Inclusion Criteria

Platelet count < 30 × 10^9/L or Platelet count < 50 × 10^9/L with clinically significant bleeding before any medical intervention
If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion
I have been diagnosed with primary ITP after other causes were ruled out.
See 3 more

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria may apply
Known sensitivity or intolerance to any products administered during study or to any Escherichia coli-derived product
I do not have any life-threatening bleeding right now.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Predniso(lo)ne
  • Romiplostim

Trial Overview

The study compares two groups: one receives both romiplostim and predniso(lo)ne, while the other gets only predniso(lo)ne. The goal is to see if adding romiplostim helps people with newly diagnosed ITP more than standard steroid treatment alone.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Romiplostim + Predniso(lo)neExperimental Treatment2 Interventions
Group II: Predniso(lo)neActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
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Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

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