A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previous… (NCT07700238) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
126 participantsStarted 2026-07-20
Plain-language 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).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 rand…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With a Durable Platelet Response (DPR)