Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty
NCT ID: NCT01713361
Last Updated: 2014-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
315 participants
INTERVENTIONAL
2012-10-31
2014-08-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ISIS-FXIRx Dose 2
Group B: ISIS-FXIRx Dose #2
ISIS-FXIRx Dose #2
Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
ISIS-FXIRx Dose 3
Group C: ISIS-FXIRx Dose #3
ISIS-FXIRx Dose #3
Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
Enoxaparin
Enoxaparin (40mg)
Enoxaparin
Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). \[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\]
Interventions
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ISIS-FXIRx Dose #2
Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
ISIS-FXIRx Dose #3
Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
Enoxaparin
Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). \[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjay Bhanot, MD, PhD
Role: STUDY_DIRECTOR
VP, Clinical Development, Isis Pharmaceuticals
Locations
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Isis Investigational Site
Plovdiv, , Bulgaria
Isis Investigational Site
Rousse, , Bulgaria
Isis Investigational Site
Sofia, , Bulgaria
Isis Investigational Site
Ajax, Ontario, Canada
Isis Investigational Site
Oshawa, Ontario, Canada
Isis Investigational Site
Ādaži, , Latvia
Isis Investigational Site
Riga, , Latvia
Isis Investigational Site
Valmiera, , Latvia
Isis Investigational Site
Chelyabinsk, , Russia
Isis Investigational Site
Orenburg, , Russia
Isis Investigational Site
Saint Petersburg, , Russia
Isis Investigational Site
Saint Petersburg, , Russia
Isis Investigational Site
Saint Petersburg, , Russia
Isis Investigational Site
Samara, , Russia
Isis Investigational Site
Yaroslavl, , Russia
Isis Investigational Site
Cherkassy, , Ukraine
Isis Investigational Site
Ivano-Frankivsk, , Ukraine
Isis Investigational Site
Kharkiv, , Ukraine
Isis Investigational Site
Kyiv, , Ukraine
Isis Investigational Site
Odesa, , Ukraine
Isis Investigational Site
Sevastopol, , Ukraine
Countries
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References
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Buller HR, Bethune C, Bhanot S, Gailani D, Monia BP, Raskob GE, Segers A, Verhamme P, Weitz JI; FXI-ASO TKA Investigators. Factor XI antisense oligonucleotide for prevention of venous thrombosis. N Engl J Med. 2015 Jan 15;372(3):232-40. doi: 10.1056/NEJMoa1405760. Epub 2014 Dec 7.
Other Identifiers
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ISIS 416858-CS3
Identifier Type: -
Identifier Source: org_study_id
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