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

NCT05070845

RecruitingPhase 2

Sponsor: Pfizer

Conditions: Primary Immune Thrombocytopenia

Interventions: PF-06835375

Countries: United States, Australia, Canada, Czechia, Hungary, Poland, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (31)
  • Greenville, North Carolina, United States
  • Liverpool, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • Mount Kuring-Gai, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Bedford Park, South Australia, Australia
  • Kurralta Park, South Australia, Australia
  • Melbourne, Victoria, Australia
  • Perth, Western Australia, Australia
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Hradec Králové, Czechia
  • Ostrava - Poruba, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Pécs, Baranya, Hungary
  • Kaposvár, Somogy County, Hungary
  • Budapest, Hungary
  • Győr, Hungary
  • Szekszárd, Hungary
  • Tatabánya, Hungary
  • Skórzewo, Greater Poland Voivodeship, Poland
  • Bialystok, Poland
  • Gdansk, Poland
  • Katowice, Poland
  • Poznan, Poland
  • Wroclaw, Poland
  • Cambridge, Cambridgeshire, United Kingdom
  • Plymouth, Devon, United Kingdom
  • Truro, England, United Kingdom
  • + 1 more on CT.gov