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

Condition(s) targeted: Dysfunctional Central Venous Access Catheters

Intervention: tenecteplase (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Genentech

Official(s) and/or principal investigator(s):
Barbara Gillespie, M.D., FASN, Study Director, Affiliation: Quintiles

Overall contact:
Trial Information Support Line, Phone: 888-662-6728

This is a Phase III, open-label, single-arm study that will be conducted at approximately 35 centers in the United States and Canada. Approximately 210 adult and pediatric subjects with dysfunctional CVA catheters will be enrolled in the study and treated with one or two doses of tenecteplase.

Official title: A Phase III, Open-Label, Single-Arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Primary outcome: Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase with a dwell time of up to 120 minutes

Secondary outcome:

Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase

Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase

Percentage of subjects who have restoration of CVA catheter function following a second administration of tenecteplase

Percentage of subjects who have restoration of CVA catheter function following a second administration of tenecteplase

Percentage of subjects who have restoration of CVA catheter function following administration of one or two doses of tenecteplase

Percentage of subjects who have restoration of CVA catheter function at any time during the study and who maintain catheter patency the next time the catheter is accessed, up to 7 days following the last dose of tenecteplase

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinically stable, in the opinion of the investigator

- CVA catheter occlusion, defined as inability to withdraw 3 mL of blood for subjects

weighing ≥ 10 kg or inability to withdraw 1 mL of blood for subjects weighing < 10 kg

- Able to have fluids infused at the volume necessary to instill study drug into the CVA

catheter

Exclusion Criteria:

- Able to have 3 mL of blood (subjects weighing ≥ 10 kg) or 1 mL of blood (subjects

weighing < 10 kg) withdrawn from the selected CVA catheter following subject repositioning

- Selected study CVA catheter inserted < 2 days prior to treatment

- Selected study CVA catheter implanted specifically for HD

- Use of a power injector on the selected study CVA catheter during the study

- Evidence of mechanical, non-thrombotic occlusion of the selected study CVA catheter

(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

- CVA catheter 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(R) (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

Trial Information Support Line, Phone: 888-662-6728

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting
Bryce Warren, Phone: 501-364-1494, Email: warrenbrycea@uams.edu

Children's Hospital & Hlth Ctr, San Diego, California 000NA, United States; Recruiting
Mehrzad Milburn, Phone: 858-966-8155, Email: mmilburn@chsd.org

Children's Hospital Oakland, Oakland, California 94609, United States; Recruiting

Miller Children's Hospital, Long Beach, California 90803, United States; Recruiting
Linda Tirabassi, Phone: 562-933-0614, Email: ltirabassi@memorialcare.org

Tampa Children's Hospital, Tampa, Florida 33677, United States; Recruiting
Pam Neu, Phone: 813-870-4252, Email: pamela.neu@baycare.org

Children's Healthcare Altanta, Atlanta, Georgia 30322, United States; Recruiting

Hope Children's Hospital, Oak Lawn, Illinois 60453, United States; Recruiting
Jane Suszek, Phone: 847-723-7570, Email: jane.suszek@advocatehealth.com

Lutheran General Hospital, Park Ridge, Illinois 60068, United States; Recruiting
Regina Schwartz, Phone: 847-723-9489

New England Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Lorraine Haley, Phone: 617-636-5535, Email: lhaley@tufts-nemc.org

Hackensack Univ Medical Center, Hackensack, New Jersey 07601, United States; Recruiting

Univerisity of New Mexico, Albuquerque, New Mexico 87131, United States; Recruiting
Nancy Eisenberg, Phone: 505-272-4461, Email: neisenberg@salud.unm.edu

Maimonides Medical Center, Brooklyn, New York 11219, United States; Recruiting
Carline Saintilien, Phone: 718-283-7374, Email: csaintilien@mamonidesmed.org

New York Medical College, Valhalla, New York 10595, United States; Recruiting
Banafsheh Sinaki, Phone: 914-594-4151, Email: banafsheh_sinaki@nymc.edu

Children's Medical Ctr. Dayton, Dayton, Ohio 45404-1815, United States; Recruiting
Sandy Hibner, Phone: 937-641-3111, Email: uhl@childrensdayton.org

Milton Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Heidi N. Watts, Phone: 717-531-4311 ID# 2618 pager, Email: hwatts@hmc.psu.edu

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Aryn Polk, Phone: 713-798-7153, Email: apolk@texaschildrenshospital.org

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Recruiting
Amy Rowell, Phone: 682-885-1904, Email: amyrow@cookchildrens.org

Virginia Commonwealth Univ, Richmond, Virginia 23219, United States; Recruiting

Starting date: December 2006
Last updated: September 27, 2008