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

Launched by IONIS PHARMACEUTICALS, INC. · Oct 23, 2012

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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 \<LLN
• • 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