Status:
COMPLETED
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Lead Sponsor:
Genentech, Inc.
Conditions:
Dysfunctional Central Venous Access Catheters
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 v...
Eligibility Criteria
Inclusion
- 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
- 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 10 kg) withdrawn from the selected study CVC following patient repositioning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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00395876
Start Date
November 1 2006
Last Update
August 10 2010
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