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

NCT00395876 | Completed Phase 3 Results

• 1 other identifier: N3698g
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dysfunctional Central Venous Access Catheters

Keywords

TNKase; CVA; CVAD; Central venous access catheter; CVA catheter

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug

  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.

  120 minutes after first dose

Secondary Outcomes (10)

• Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug

  15 minutes after first dose

• Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug

  30 minutes after first dose

• Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug

  15 minutes after second dose

• Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug

  30 minutes after second dose

• Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug

  120 minutes after second dose

Study Arms (2)

Placebo + Tenecteplase + Tenecteplase (PTT)

PLACEBO COMPARATOR

Drug: placebo; Drug: tenecteplase

Tenecteplase + Tenecteplase + Placebo (TTP)

EXPERIMENTAL

Drug: placebo; Drug: tenecteplase

Interventions

placebo DRUG

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).

Placebo + Tenecteplase + Tenecteplase (PTT); Tenecteplase + Tenecteplase + Placebo (TTP)

tenecteplase DRUG

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).

Placebo + Tenecteplase + Tenecteplase (PTT); Tenecteplase + Tenecteplase + Placebo (TTP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

• Gabrail N, Sandler E, Charu V, Anas N, Lim E, Blaney M, Ashby M, Gillespie BS, Begelman SM. TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters. J Vasc Interv Radiol. 2010 Dec;21(12):1852-8. doi: 10.1016/j.jvir.2010.09.002.

  PMID: 21111365 DERIVED

MeSH Terms

Interventions

Tenecteplase

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Richard Levine, M.D.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Last Updated: August 10, 2010
• Results First Posted: August 10, 2010

Record last verified: 2010-07