A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)
A legfontosabb adatok
- Hol
- Fredericksburg, Long Beach és Peoria (Egyesült Államok)Mind a 3 helyszín megnézése
- Fázis
- 3. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 100 év között vagy?
Forrás: NCT07700238: ki vehet részt
Helyszínek itt: Egyesült Államok
- Hematology Oncology Associates of FredericksburgFredericksburg, Egyesült ÁllamokRésztvevőt keres
- MemorialCare Long Beach Medical CenterLong Beach, Egyesült ÁllamokRésztvevőt keres
- The Bleeding and Clotting Disorders InstitutePeoria, Egyesült ÁllamokRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Amgen
- Azonosító
- NCT07700238
- A regiszteradat frissítve
- 2026. szeptember 17.
- Eredeti leírás
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).A teljes eredeti leírásKevesebb
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).
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).
Bevonási feltételek: 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.
Kizáró feltételek: 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.