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

NCT00395876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-08-10

Study results available

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

Interventions

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).

Sponsors & Collaborators

Genentech, Inc.
lead INDUSTRY

Principal Investigators

Richard Levine, M.D.

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2006-11-30
Primary Completion: 2008-06-30

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Entities

Drugs

Placebo