A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters (TROPICS 1)

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00395876
First received: November 2, 2006
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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).


Condition Intervention Phase
Dysfunctional Central Venous Access Catheters
Drug: placebo
Drug: tenecteplase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug [ Time Frame: 120 minutes after first dose ] [ Designated as safety issue: No ]
    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:
  • Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug [ Time Frame: 15 minutes after first dose ] [ Designated as safety issue: No ]
    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 Single Administration of Study Drug [ Time Frame: 30 minutes after first dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes after second dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes after second dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 120 minutes after second dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes after third dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes after third dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 120 minutes after third dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 120 minutes post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 7 days post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: November 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Tenecteplase + Tenecteplase (PTT) Drug: placebo
2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug 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).
Drug: tenecteplase
2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug 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).
Experimental: Tenecteplase + Tenecteplase + Placebo (TTP) Drug: placebo
2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing < 30 kg received instillations of study drug 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).
Drug: tenecteplase
2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of study drug 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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395876

Sponsors and Collaborators
Genentech
Investigators
Study Director: Richard Levine, M.D.
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00395876     History of Changes
Other Study ID Numbers: N3698g
Study First Received: November 2, 2006
Results First Received: July 14, 2010
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
TNKase
CVA
CVAD
Central venous access catheter
CVA catheter

Additional relevant MeSH terms:
Tenecteplase
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014