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

NCT ID: NCT00396318

Last Updated: 2011-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

Brief 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.

Conditions

Dysfunctional Central Venous Access Catheters

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenecteplase

Group Type: EXPERIMENTAL

tenecteplase

Intervention Type: DRUG

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).

Interventions

tenecteplase

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 Type: DRUG

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 10 kg) withdrawn from the selected CVC following patient repositioning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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Genentech, Inc.

Principal Investigators

Barbara Gillespie, M.D., FASN

Role: STUDY_DIRECTOR

Quintiles, Inc.

Other Identifiers

N3699g

Identifier Type: -

Identifier Source: org_study_id