Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Primary Immune Thrombocytopenia
Age (in years)
18 - 70
Phase
Phase 2
Participants needed
61
Est. Completion Date
Mar 21, 2025
Treatment type
Interventional
Sponsor
Pfizer
ClinicalTrials.gov identifier
NCT05070845
Study number
C1131003
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