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

Recruiting now · Phase 2

Conditions studied: Primary Immune Thrombocytopenia

In brief

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

Key facts

Study ID

NCT05070845

Run by

Pfizer

People needed

91

Starts

2022-02-02

Expected to finish

2028-08-02

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Liverpool Hospital — Liverpool, New South Wales, Australia (enrolling)
• South West Radiology — Liverpool, New South Wales, Australia (enrolling)
• Slade Pharmacy — Mount Kuring-Gai, New South Wales, Australia (enrolling)
• Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• ICON Cancer Centre - Kurralta Park — Kurralta Park, South Australia, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Royal Perth Hospital — Perth, Western Australia, Australia (enrolling)
• Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
• Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia (enrolling)
• Fakultni nemocnice Ostrava — Ostrava - Poruba, Czechia (enrolling)
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia (enrolling)
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia (enrolling)
• Pratia Onkologia Katowice — Katowice, Poland (enrolling)
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw, Poland (enrolling)
• Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom (enrolling)
• Derriford Hospital — Plymouth, Devon, United Kingdom (enrolling)
• The Royal Cornwall Hospital — Truro, England, United Kingdom (enrolling)
• Hammersmith Hospital — London, United Kingdom (enrolling)
• Somogy Megyei Kaposi Mór Oktató Kórház — Kaposvár, Somogy County, Hungary (enrolling)
• Semmelweis University — Budapest, Hungary (enrolling)
• Petz Aladár Egyetemi Oktató Kórház — Győr, Hungary (enrolling)
• AIDPORT Sp. z o.o. — Skórzewo, Greater Poland Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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