A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Condition: Dysfunctional Central Venous Access Catheters
Intervention: placebo; tenecteplase
Intervention description: 2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug 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).; 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug 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: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Healthy volunteers: No
Keywords: TNKase; CVA; CVAD; Central venous access catheter; CVA catheter

Summary:

      This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted
      at 24 centers in the United States and Canada. 100 adult and pediatric patients with
      dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to
      receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).
    

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 10 kg) withdrawn from the selected study CVC following patient
             repositioning

          -  Selected study CVC inserted < 2 days prior to treatment

          -  Selected study CVC known to be dysfunctional for > 7 days

          -  Selected study CVC implanted specifically for hemodialysis (HD)

          -  Use of a power injector on the selected study CVC during the study

          -  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

          -  CVC with known or suspected infection

          -  History of any intracranial hemorrhage, aneurysm, or arteriovenous malformation

          -  Use of heparin (unfractionated or low molecular weight) within 24 hours prior to
             treatment, except for use of intermittent or low-dose, continuous infusion of heparin
             to maintain catheter or vessel patency

          -  Use of warfarin within 7 days prior to treatment, except for low-dose warfarin used
             for prophylaxis

          -  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