A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

Phase 3

Completed

Conditions: Dysfunctional Central Venous Access Catheters

Interventions: Drug: placebo
Drug: tenecteplase

Registration Number: NCT00395876

Lead Sponsor: Genentech, Inc.

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 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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 10 kg) withdrawn from the selected study CVC following patient repositioning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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Tenecteplase + Tenecteplase (PTT)	placebo	-
Tenecteplase + Tenecteplase + Placebo (TTP)	placebo	-
Placebo + Tenecteplase + Tenecteplase (PTT)	tenecteplase	-
Tenecteplase + Tenecteplase + Placebo (TTP)	tenecteplase	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug	120 minutes after first dose	Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug	30 minutes after first dose	Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug	120 minutes after second dose	Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug	120 minutes after third dose	Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase	Up to 120 minutes post-treatment	Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.
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	Up to 7 days post-treatment	Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \< 10 kg.