Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
Recruiting
Phase 2Interventional Study
Primary Immune Thrombocytopenia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
91 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
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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
Trial Locations
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Status
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 …
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.
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