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

Launched by PFIZER · Sep 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PF-06835375 for adults with a condition known as primary immune thrombocytopenia (ITP), which is when the body doesn’t make enough platelets, leading to a higher risk of bleeding. The trial is focused on adults who have had ongoing ITP for at least three months but less than twelve months (persistent ITP), or more than twelve months (chronic ITP). The study is currently recruiting participants aged 18 to 75, regardless of gender, who have low platelet counts and haven’t had any severe bleeding events recently.

If you decide to participate, you will receive multiple injections of the study medication and will be monitored closely for any side effects and how well the treatment works. It’s important to note that individuals with recent severe bleeding, those needing certain treatments, or who have had a specific surgery related to this condition recently may not be eligible. This trial aims to see if the new treatment can help improve platelet counts and overall health for those living with ITP.

Gender

ALL

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.