Peripherally Inserted Central Catheters (PICCs) are commonly used in patients with cancer to administer chemotherapy and supportive care medication. However, PICCs and other medical devices that come into contact with blood increase the risk of blood clots (thrombosis) inside the blood vessels. Conventional blood thinners (anticoagulants) may reduce the risk of thrombosis but they also increase the risk of bleeding. CSL312, a monoclonal antibody that inhibits the activated blood clotting factor 12 (FXIIa) will be assessed for its potential to prevent thrombus formation in subjects with cancer at risk of PICC-associated thrombosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Number of subjects with PICC-associated thrombosis
PICC-associated thrombosis which can be either: 1. Asymptomatic PICC associated thrombosis detected by Duplex ultrasound (DUS) or venography at Day 15 or Day 29 after PICC insertion or 2. Symptomatic PICC associated thrombosis up to Day 29 after PICC insertion, suspected clinically due to symptoms of the upper limb or neck, and objectively confirmed by DUS or venography
Time frame: Up to 29 days after PICC insertion
Percent of subjects with PICC-associated thrombosis
PICC-associated thrombosis which can be either: 1. Asymptomatic PICC associated thrombosis detected by Duplex ultrasound (DUS) or venography at Day 15 or Day 29 after PICC insertion or 2. Symptomatic PICC associated thrombosis up to Day 29 after PICC insertion, suspected clinically due to symptoms of the upper limb or neck, and objectively confirmed by DUS or venography
Time frame: Up to 29 days after PICC insertion
Overall percentage of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 110 days after first dose of CSL312
Percent of subjects with related TEAEs
Time frame: Up to 110 days after first dose of CSL312
Percent of subjects with TEAEs by severity
Time frame: Up to 110 days after first dose of CSL312
Number of subjects treated with CSL312 with detectable antibodies to CSL312
Time frame: Up to 110 days after first dose of CSL312
Percent of subjects treated with CSL312 with detectable antibodies to CSL312
Time frame: Up to 110 days after first dose of CSL312
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Maximum plasma concentration (Cmax) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Area under the concentration-time curve (AUC0-t) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Time of maximum plasma concentration (Tmax) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Terminal elimination half-life (T1/2) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Total systemic clearance (CLtot) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Volume of distribution during the elimination phase (Vz) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Accumulation Ratio (AR) of CSL312
Time frame: Up to 110 days after first dose of CSL312
Number of subjects with thrombosis-associated catheter occlusion
Time frame: Up to 29 days after first dose of CSL312
Percent of subjects with thrombosis-associated catheter occlusion
Time frame: Up to 29 days after first dose of CSL312
Number of subjects with PICC removal or replacement
Time frame: Up to 29 days after first dose of CSL312
Percent of subjects with PICC removal or replacement
Time frame: Up to 29 days after first dose of CSL312
Number of subjects with central line-associated blood stream infections (CLABSI)
Time frame: Up to 29 days after first dose of CSL312
Percent of subjects with CLABSI
Time frame: Up to 29 days after first dose of CSL312