RecruitingPhase 2NCT05070845
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
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
Sponsor
Pfizer
Enrollment
91 participants
Start Date
Feb 2, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria1
- 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
Exclusion Criteria2
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BIOLOGICALPF-06835375
CXCR5 inhibitor
Locations(31)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05070845
Related Trials
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
NCT0703942222 locations
Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)
NCT061075821 location
A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia
NCT0690092053 locations
Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.
NCT065310181 location
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
NCT066869271 location