Randomized, Double blind, Phase II Trial of Vortosiran to Evaluate Safety, Tolerability, and Pharmacodynamic Efficacy in Participants with Prior Venous Thromboembolism After Completion of Initial Anticoagulant Therapy (Cohort A) and in Cancer Patients at High Risk of Venous Thromboembolism (Cohort B)

Condition studied

Venous Thromboembolism

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percentage change from baseline in FXI activity, compared with placebo at Week 8.

Endpoint detail

Frequency, intensity, and seriousness of AEs during the trial, as well as clinically significant changes in laboratory parameters, vital signs, physical examinations, and 12-lead ECGs, Plasma concentrations of vortosiran, summarized with descriptive statistics by dose and sampling timepoint, Change from baseline and percentage change from baseline in FXI activity after dosing of vortosiran, compared with placebo, over the trial period, Change from baseline and percentage change from baseline in aPTT, PT/INR and FXI antigen levels after dosing of vortosiran, compared with placebo, over the trial period.