Skip to content

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

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

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 70

Participation 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.

Study Location

Unity Health Toronto, St. Michael's Hospital
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario
Canada

Contact Study Team

McGill University Health Centre
McGill University Health Centre
Montreal, Quebec
Canada

Contact Study Team

Study Sponsored By
Pfizer
Participants Required
More Information
Study ID: NCT05070845