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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
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
About the study
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
What is being tested
- PF-06835375 (biological)
Sponsor: Pfizer · Participants: 91 · Started: Feb 2, 2022
Contact the study team
- Pfizer CT.gov Call Center · Phone: 1-800-718-1021
Official record on ClinicalTrials.gov — NCT05070845
Locations in the U.S.
| North Carolina | East Carolina University, Greenville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.