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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Dysfunctional Central Venous Access Catheters
Intervention:	Drug: tenecteplase

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 246.

Reporting Groups

	Description
Tenecteplase	2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.

Description

Tenecteplase

2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.

Participant Flow for 3 periods

Period 1: At Least One Dose of Tenecteplase (MITT)

	Tenecteplase
STARTED	246
COMPLETED	241
NOT COMPLETED	5
Subject withdrew consent	5

Period 2: 48- to 96-Hour Follow-Up Period

	Tenecteplase
STARTED	246
COMPLETED	241
NOT COMPLETED	5

Period 3: 7-Day Post-Treatment Contact

	Tenecteplase
STARTED	241
COMPLETED	240
NOT COMPLETED	1

Baseline Characteristics

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Reporting Groups

	Description
Tenecteplase	2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.

Description

Tenecteplase

2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. 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. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.

Baseline Measures

	Tenecteplase
Number of Participants [units: participants]	246
Age [units: Years] Mean ± Standard Deviation	43.6 ± 26.4
Age, Customized [units: participants]
< 2 years	10
≥ 2 to < 17 years	62
≥ 17 to < 65 years	111
≥ 65 years	63
Gender [units: participants]
Female	155
Male	91

Outcome Measures

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1. Primary:

Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase [ Time Frame: 120 minutes after first dose ]

Show Outcome Measure 1

2. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase [ Time Frame: 15 minutes after first dose ]

Show Outcome Measure 2

3. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase [ Time Frame: 30 minutes after first dose ]

Show Outcome Measure 3

4. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase [ Time Frame: 15 minutes after second dose ]

Show Outcome Measure 4

5. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase [ Time Frame: 30 minutes after second dose ]

Show Outcome Measure 5

6. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase [ Time Frame: 120 minutes after second dose ]

Show Outcome Measure 6

7. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase [ Time Frame: Up to 120 minutes post-treatment (Dose 1 or Dose 2) ]

Show Outcome Measure 7

8. Secondary:

Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates 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 ]

Show Outcome Measure 8

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00396318 History of Changes
Other Study ID Numbers:	N3699g
Study First Received:	November 2, 2006
Results First Received:	September 19, 2010
Last Updated:	March 29, 2011
Health Authority:	United States: Food and Drug Administration

A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters (TROPICS 2)