At a glance
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A Phase 2B, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversing Ticagrelor in Subjects Aged 50 to 80 Years Old
In Brief
A Phase 2 clinical trial evaluating Ticagrelor Oral Tablet - Pre-Treatment, Aspirin (ASA) Oral Tablet - Pre-Treatment, and 2 other interventions for Healthy. Completed, enrolled 207 participants across 15 sites in 2 countries.
Detailed Summary
This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old. A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.
Study Details
Timeline
Interventions
Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion.
0.9% Sodium chloride Intravenous Infusion over a 16 hour duration