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Taking people in United StatesPhase 3

Romiplostim added to prednisone for untreated immune thrombocytopenia in adults

Tests romiplostim plus prednisone in adults with untreated immune thrombocytopenia.

Key facts

Who runs it
Amgen
Where
Fredericksburg, Long Beach, and Peoria, United StatesSee the 3 sites
Trial code
Registry title
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
Status
Recruiting
Phase
Phase 3
People taking part
126 people, planned
Started
21 Aug 2026
Expected to end
14 Oct 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Romiplostim
  • Predniso(lo)ne
Record updated
17 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary immune thrombocytopenia (ITP, low platelets caused by the immune system) who have not been treated yet and need treatment. It compares romiplostim plus predniso(lo)ne with predniso(lo)ne alone.

Age
18 to 100 years, or the adult legal age in the country if older than 18 years.
Sex
All sexes can join.
Disease stage
Primary ITP diagnosed by the 2019 International Consensus, not treated before, and needing treatment. Other causes of low platelets must be ruled out.
Earlier treatment
No earlier ITP treatment. Emergency treatment with thrombopoietin receptor agonists (TPO-RAs) or spleen removal (splenectomy) is not allowed.
Biomarker or test result
Platelet count < 30 × 10^9/L, or < 50 × 10^9/L with clinically significant bleeding, before any medical treatment.

Main reasons for not taking part

  • Life-threatening bleeding at randomization.
  • Spleen fully removed in the past.
  • Use of blood thinners or antiplatelet drugs, or NSAIDs within 7 days before randomization.
  • A blood clot in a vein within 3 months or an artery within 6 months before randomization.
  • Uncontrolled high blood pressure, abnormal liver or kidney function, or intolerance to study drugs or Escherichia coli-derived products.

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Age ≥18 years or adult legal age within country if older than 18 years
  • Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment; Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia; Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion; Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed
  • Platelet count < 30 × 10\^9/L or Platelet count < 50× 10\^9/L with clinically significant bleeding before any medical intervention

Who cannot take part

  • Use of concurrent anticoagulation therapy and/or antiplatelet therapy
  • Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization
  • Life-threatening bleeding at randomization
  • Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins)
  • Uncontrolled hypertension before randomization
  • History of total splenectomy
  • Abnormal hepatic or renal function at screening
  • Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization
  • Other protocol-defined Inclusion/Exclusion may apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Where in United States

  • Hematology Oncology Associates of FredericksburgFredericksburg, United StatesTaking people
  • MemorialCare Long Beach Medical CenterLong Beach, United StatesTaking people
  • The Bleeding and Clotting Disorders InstitutePeoria, United StatesTaking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Romiplostim + Predniso(lo)neTreatment being tested

    Participants will receive romiplostim administered subcutaneously (SC) in combination with predniso(lo)ne administered orally during Part 1 of the study. Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.

    Treatment: Romiplostim and Predniso(lo)ne

  • Predniso(lo)neExisting treatment, for comparison

    Participants will receive predniso(lo)ne administered orally during Part 1 of the study. Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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).
Plain-language title
Romiplostim added to prednisone for untreated immune thrombocytopenia in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07700238, who can take part
Record updated
17 September 2026