Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396253
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2006-11-02
Brief Title:
A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis HD Catheters
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase III Open-Label Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis HD Catheters
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TROPICS 4
Brief Summary:
This was a Phase III open-label study conducted at 44 centers in the United States Canada and Puerto Rico 223 subjects who required hemodialysis HD and had a dysfunctional HD catheter were enrolled in the study
Detailed Description:
The study consisted of four visits that corresponded to consecutive HD sessions for each patient as well as one follow-up visit Patients could receive up to three treatments with open-label tenecteplase during the study one or two treatments during an initial treatment course and eligible patients whose catheter became dysfunctional again within 21 days of the first visit received an additional treatment as part of a retreatment RT course
At Visit 1 patients eligible at the beginning of HD had 2 mL 2 mg of tenecteplase instilled into each of the two lumens of the HD catheter After a dwell time of 1 hour study drug was withdrawn and all subjects underwent HD The duration of the HD session was not fixed by the study protocol but rather by the sites HD practice physician orders and individual patient response during the session Patients who did not experience treatment success at the end of Visit 1 had 2 mL 2 mg of tenecteplase instilled into each lumen of their catheter as part of the initial treatment course The treatment was left to dwell for an extended time until the second HD session at Visit 2 up to 72 hours later Patients who received extended-dwell tenecteplase had the treatment withdrawn from their catheter at the beginning of Visit 2 Patients underwent HD as prescribed or to the extent possible
Patients who had treatment success at Visit 1 or Visit 2 and had a recurrence of catheter dysfunction within 21 days of Visit 1 and met the re-treatment eligibility criteria had 2 mL 2 mg of tenecteplase instilled into each lumen followed by a 1-hour dwell time at re-treatment Visit 1
At Visit 1 patients eligible at the beginning of HD had 2 mL 2 mg of tenecteplase instilled into each of the two lumens of the HD catheter After a dwell time of 1 hour study drug was withdrawn and all subjects underwent HD The duration of the HD session was not fixed by the study protocol but rather by the sites HD practice physician orders and individual patient response during the session Patients who did not experience treatment success at the end of Visit 1 had 2 mL 2 mg of tenecteplase instilled into each lumen of their catheter as part of the initial treatment course The treatment was left to dwell for an extended time until the second HD session at Visit 2 up to 72 hours later Patients who received extended-dwell tenecteplase had the treatment withdrawn from their catheter at the beginning of Visit 2 Patients underwent HD as prescribed or to the extent possible
Patients who had treatment success at Visit 1 or Visit 2 and had a recurrence of catheter dysfunction within 21 days of Visit 1 and met the re-treatment eligibility criteria had 2 mL 2 mg of tenecteplase instilled into each lumen followed by a 1-hour dwell time at re-treatment Visit 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None