Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Megadott ok: The study terminated due to a business decision. The decision to terminate the trial was not based on any safety concerns.
A legfontosabb adatok
- Hol
- Greenville (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- East Carolina UniversityGreenville, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Pfizer
- Azonosító
- NCT05070845EU 2023-509338-21-00
- A regiszteradat frissítve
- 2026. október 16.
- Eredeti leírás
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITPA teljes eredeti leírásKevesebb
AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITP
Bevonási feltételek: Diagnosis of Primary ITP. Ongoing ITP (platelet counts <50 x 109/L) [No severe bleeding within 1 month or during screening] AND Persistent ITP (3 to 12 months) or Chronic ITP >12 months.
Kizáró feltételek: Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening; Splenectomy within 3 months of randomization or planned during the study duration.