An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty

Ionis Pharmaceuticals, Inc.1 site in 1 country315 target enrollmentOctober 2012

Overview

The purpose of this study is:

To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty.
To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Give written informed consent
•Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception
•Undergoing elective, primary unilateral total knee arthroplasty

•Body weight \<50 kg
•Patients at increased risk of bleeding. History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year.
•History of excessive intra- or direct post operative bleeding or a traumatic spinal or epidural anesthesia
•Brain, spinal, or ophthalmologic surgery within the past 3 months
•History of clinically significant liver disease in the past year
•Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values
•aPTT or PT or INR \>ULN
•Factor IX activity \<LLN
•Factor VIII activity, vWF antigen or Ristocetin cofactor activity \<0.5 U/mL
•FXI activity \<0.3 U/mL