Clinical Trials in the USA / NCT07700238
Recruiting
Phase 3
A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
NCT07700238 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Primary Immune Thrombocytopenia
Investigational drug(s) / intervention(s)
Romiplostim: Administered subcutaneously.
Predniso(lo)ne: Administered orally.
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Percentage of Participants With a Durable Platelet Response (DPR) — 8 weeks
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| MemorialCare Long Beach Medical Center | Long Beach | California | Recruiting |
| The Bleeding and Clotting Disorders Institute | Peoria | Illinois | Recruiting |
| Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia | Recruiting |
More Amgen trials in the USA
Other trials for the same condition
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07700238 on ClinicalTrials.gov ↗ ← All trials in the USA