A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Condition: Dysfunctional Central Venous Access Catheters
Intervention: tenecteplase
Intervention description: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.
Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).
Intervention MeSH terms: Tenecteplase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Healthy volunteers: No
Keywords: TNKase; CVA; CVAD; Central venous access catheter

Summary:

      This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the
      United States and Canada. 251 adult and pediatric patients with dysfunctional central venous
      catheters (CVCs) were enrolled in the study and treated with one or two doses of
      tenecteplase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically stable, in the opinion of the investigator

          -  CVC occlusion

          -  Able to have fluids infused at the volume necessary to instill study drug into the CVC

        Exclusion Criteria:

          -  Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients
             weighing < 10 kg) withdrawn from the selected CVC following patient repositioning

          -  Selected study CVC inserted < 2 days prior to treatment

          -  Selected study CVC implanted specifically for hemodialysis (HD) or internally coated
             with any therapeutic agent

          -  Use of a power injector on the selected study CVC during study drug treatment

          -  Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (e.g., kink
             in the catheter or suture constricting the catheter)

          -  Previously treated in this study or any tenecteplase catheter clearance trial

          -  Use of any investigational drug or therapy within 28 days prior to treatment

          -  Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase)
             within 24 hours prior to treatment

          -  Known to be pregnant or breastfeeding at screening

          -  Known bacteremia or known or suspected infection in the CVC catheter

          -  Known history of intracranial hemorrhage (within the previous 3 years), intracranial
             aneurysm, or arteriovenous malformation

          -  Use of heparin (unfractionated or low molecular weight) or any other anticoagulants
             within 24 hours prior to treatment, except heparin used for prophylaxis or
             intermittent or low-dose, continuous infusion of heparin to maintain catheter or
             vessel patency

          -  Subjects treated with warfarin only: international normalized ratio (INR) ≥ 3.0 within
             7 days prior to Visit 1, or a target INR range that allows for an INR ≥ 3.0

          -  Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days
             prior to treatment

          -  At high risk for bleeding events or embolic complications (i.e., recent pulmonary
             embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left
             shunt) in the opinion of the investigator, or with known condition for which bleeding
             constitutes a significant hazard

          -  Known hypersensitivity to tenecteplase or any component of the formulation