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Not yet recruiting NCT07700238

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

Phase III Interventional Primary Immune Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Romiplostim, Predniso(lo)ne.
Who it may be relevant to
Registry conditions: Primary Immune Thrombocytopenia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Overview

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).

Interventions

  • Drug Romiplostim
    Administered subcutaneously.
  • Drug Predniso(lo)ne
    Administered orally.

Primary outcome measures

  • Percentage of Participants With a Durable Platelet Response (DPR) [Time frame: 8 weeks]
Secondary outcome measures (9)
  • Time to Next Treatment (TTNT) [Time frame: 12 months]
  • Cumulative Exposure to Corticosteroids [Time frame: 12 months]
  • Change From Baseline in ITP Patient Assessment Questionnaire (ITP-PAQ) [Time frame: 12 months]
  • Change in Summary Scores and Visual Analogue Scale (VAS) Scores per EuroQol 5-Dimension 5-Level (EQ 5D-5L) [Time frame: 12 months]
  • Incidence of Hospitalization and Rescue Medication in Part 1 [Time frame: 6 months]
  • Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Interest (EOI), and Fatal TEAEs [Time frame: 12 months]
  • Percentage of Participants With Clinically Significant Bleeding Events in the Immune Thrombocytopenia-specific Bleeding Assessment Tool (ITP-BAT) [Time frame: 6 months]
  • Serum Trough Concentration (Ctrough) of Romiplostim [Time frame: 6 months]
  • Number of Participants With Anti-Romiplostim Antibodies and Anti-Thrombopoietin (TPO) Antibodies [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Abnormal hepatic or renal function at screening.
  • History of total splenectomy.
  • 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.
  • Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization.
  • Other protocol-defined Inclusion/Exclusion may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07700238 · 20250124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗