Phase 3
N=100
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Dysfunctional Central Venous Access Catheters
Bottom Line
View on ClinicalTrials.gov: NCT00395876 ↗Enrolled (actual)
100
Serious AEs
3.1%
Results posted
Aug 2010
Primary outcome: Primary: Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug — 23.4; 60.0 percentage of participants — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); tenecteplase (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug |
23.4; 60.0 | 0.0002 sig |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug |
19.1; 44.0 | 0.0093 sig |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug |
19.1; 44.0 | 0.0093 sig |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug |
72.3; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug |
72.3; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug |
72.3; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug |
85.1; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug |
85.1; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug |
85.1; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase |
72.3; 60.0; 85.1; 88.0 | — |
| SECONDARY Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase |
81.5; 79.3 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00395876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.