NCT07700238 · Amgen
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
(ROMISTER)
What this study is about
This Phase 3 study is designed to evaluate the effectiveness 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).
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 criteria
- 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.
Where
- Long Beach, California
- Peoria, Illinois
- Fredericksburg, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations