drugset / Trial / NCT04281524

A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line

NCT04281524 ↗

Phase 1/2 Withdrawn CSL Behring
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2020-03
Primary completion
2021-08
Completion
2021-10

Outcome

Outcome not reported

Stopped (Business): “Business decision non-safety related.”

Drugs

EvaluationDrugModalityDoseRoute
Subject CSL312 Monoclonal antibody — Intravenous

Indications