Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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- Factor VIII activity, vWF antigen or Ristocetin cofactor activity <0.5 U/mL

• FXI activity <0.3 U/mL

• Urine protein or blood persistently positive by dipstick. In the event of positive test results, eligibility may be confirmed with urine microscopy or 24 hour urine protein measurement as applicable

• ALT or AST >1.5 x ULN

• Total bilirubin >ULN

• Platelet count <150,000 (or history of thrombocytopenia)

• Hypersensitivity to enoxaparin

• Anticipated concomitant use of anticoagulants/antiplatelet agents or the NSAID nimesulide that may affect study outcome or any other drug influencing coagulation (except low dose aspirin and short acting NSAIDs with a half-life <20 hours) at least 7 days before surgery or during treatment with ISIS Rx.

• Anticipated use of indwelling intrathecal or epidural catheters

• Anemia at Screening

• Have any other conditions which could interfere with the patient participating in or completing the study