A Phase 2 interventional study of ISIS-FXIRx Dose #2 and ISIS-FXIRx Dose #3 in Venous Thromboembolism, sponsored by Ionis Pharmaceuticals, Inc.. Completed at 21 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-27.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 2, Interventional, and Prevention
The purpose of this study is:
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 315 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Ionis Pharmaceuticals, Inc. is the lead sponsor of 116 studies on the registry; 10 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 21 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values
Group B: ISIS-FXIRx Dose #2
Drug: ISIS-FXIRx Dose #2
Group C: ISIS-FXIRx Dose #3
Drug: ISIS-FXIRx Dose #3
Enoxaparin (40mg)
Drug: Enoxaparin
Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
Also known as: ISIS-FXIRx
Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
Also known as: ISIS-FXIRx
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). \[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\]
Also known as: Lovenox, Clexane
Primary efficacy outcome
Composite of asymptomatic DVT (via bilateral venography), and symptomatic VTE, fatal PE, and unexplained death.
Time frame: up to 12 days post-surgery
Secondary efficacy outcome
All DVTs and PEs up to 4 weeks after bilateral venography
Time frame: 1st dose to up to Day 76
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Ionis Pharmaceuticals, Inc.