260
Participants
Start Date
October 10, 2022
Primary Completion Date
October 10, 2025
Study Completion Date
October 10, 2026
Glenzocimab
"Glenzocimab (ACT-017, Acticor Biotech) is formulated for IV administration as a sterile product with 20 mM sodium citrate and 130 mM sodium chloride buffer at pH of 5.0.~It is supplied for clinical trial use in vials containing 50 mL of the drug product at a concentration of 10 mg/mL.~Each vial contains 500 mg of glenzocimab. Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total daily dose of 1g.~Glenzocimab is intended to be administered as an IV infusion over 6 hrs, with 1/4 of the dose administered by a 15-minute bolus and 3/4 of the dose administered by 5h45min-slow infusion."
Placebo
Placebo of glenzocimab is 0.9%NaCl (Acticor Biotech) for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo of glenzocimab should be administered concomitantly for eligible patients.
Assistance Publique - Hôpitaux de Paris
OTHER