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

Condition(s) targeted: Dysfunctional Central Venous Access Catheters

Intervention: placebo (Drug); tenecteplase (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Genentech

Official(s) and/or principal investigator(s):
Richard Levine, M.D., Study Director, Affiliation: Quintiles

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

This is a Phase III, randomized, double-blind, placebo-controlled study that will be conducted at approximately 25 centers in the United States and Canada. Approximately 100 adult and pediatric subjects with dysfunctional CVA catheters will be randomly assigned in a 1: 1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Primary outcome: Percentage of subjects who have restoration of CVA catheter function following a single administration of study drug

Secondary outcome:

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

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

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

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

Percentage of subjects who have restoration of CVA catheter function following a third administration of study drug

Percentage of subjects who have restoration of CVA catheter function following a third administration of study drug

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 study drug

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

- 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 study CVA catheter following subject repositioning

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

- Selected study CVA catheter known to be dysfunctional for > 7 days

- 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

Northwest Alabama Cancer Ctr, Muscle Shoals, Alabama 35661, United States; Recruiting

Northwest Alabama Cancer Ctr, Florence, Alabama 35630, United States; Recruiting

Clopton Clinic, Jonesboro, Arkansas 72401, United States; Recruiting
Amber Moon, Phone: 870-910-7723, Email: amber.moon@cloptonclinic.com

Children's Hosp of Orange Cty, Orange, California 92868-3835, United States; Recruiting
Stephanie Wronski, Phone: 714-289-4064, Email: swronski@choc.org

Eduardo Lim, MD Med Corp, Los Angeles, California 90057, United States; Recruiting
Lieu Dang, Phone: 562-988-2278, Email: ldang@armserv.com

Nemours Childrens Clinic, Jacksonville, Florida 32207, United States; Recruiting
Nicole Sanford, Phone: 904-390-3791, Email: nsanford@nemours.org

Memorial Health University, Savannah, Georgia 31405, United States; Recruiting
Victoria Taylor, Phone: 912-350-8568, Email: taylovi2@memorialhealth.com

Advocate Christ Hospital, Oak Lawn, Illinois 60453, United States; Recruiting

Advocate Luth C Hosp-Pk Ridge, Park Ridge, Illinois 60068, United States; Recruiting
Ramona Donovan, Phone: 847-723-7157, Email: ramona.donovan@advocatehealth.com

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Rosie Howard, Phone: 312-942-7902, Email: rosie_howard@rush.net

Southern Ill HemOnc-Centralia, Centralia, Illinois 62801, United States; Recruiting

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting

Hem & Onc Specialists, Covington, Louisiana 70433, United States; Recruiting
Mary Ann Ostraske, Phone: 504-349-6336, Email: mostroske1@salco.net

Hem Onc Specialities, Marrero, Louisiana 70072, United States; Recruiting
Nadia Gautier, Phone: 504-349-6323, Email: ngautier@salco.net

Hematology/Onc Specialists, Metairie, Louisiana 70006, United States; Recruiting
Nicole Guttierrez, Phone: 504-883-2968, Email: nguttierrez@salco.net

Univ of Mass Memorial, Worcester, Massachusetts 01655, United States; Recruiting
Peter Gentile, Phone: 508-856-6889, Email: gentilep@ummhc.org

William Beaumont Hospital, Royal Oak, Michigan 48072, United States; Recruiting

St. John's Mercy Medical Ctr, Saint Louis, Missouri 63141, United States; Recruiting
Heather Licata, Phone: 314-251-6986

Donald Berdeaux, MD - PP, Great Falls, Montana 59405, United States; Recruiting

Hackensack Univ Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Maureen Matullo, Phone: 201-336-8192, Email: mmatullo@humed.com

Schneider Children's Hospital, New Hyde Park, New York 11042, United States; Recruiting
Ellen Muir, Phone: 718-470-3605, Email: emuir@nshs.edu

Wake Forest University, Winston-Salem, North Carolina 27157, United States; Recruiting
Jennifer Black, Phone: 336-716-9342, Email: jhblack@wfubmc.edu

Gabrail Cancer Center, Dover, Ohio 44622, United States; Recruiting
Carrie Smith, Phone: 330-492-3345, Ext: 208, Email: csmith@gabrailcancercenter.com

Signal Point Hem/Oncology Inc, Middletown, Ohio 45042, United States; Recruiting
Susan Smith, Phone: 513-423-0504, Ext: 7, Email: susan_smith@swohio.twcbc.com

University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Jennifer McGuire, Phone: 513-584-2207, Email: mcquirjn@ucmail.uc.edu

Baylor Univ Medical Center, Dallas, Texas 75246, United States; Recruiting
Erica Chou, Phone: 214-820-6709, Email: ericacho@baylorhealth.edu

Driscoll Child, Corpus Christi, Texas 78411, United States; Recruiting
Jill Meredith, Phone: 361-694-4333, Email: jill.meredith@dchstx.org

Lone Star Oncology Consultants, Austin, Texas 78759, United States; Recruiting
Marta Johnson, Phone: 512-343-2103, Email: martaj@lonestaroncology.com

Specially for Children, Austin, Texas 78701, United States; Recruiting
Rhea Robinson, Phone: 512-912-2761, Email: rhea.robinson@usoncology.com

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