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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

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 to 70

Critères de participation

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.

Lieu de l'étude

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

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

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Étude parrainée par
Pfizer
Participants recherchés
Plus d'informations
ID de l'étude: NCT05070845