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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00396318
First received: November 2, 2006
Last updated: March 29, 2011
Last verified: March 2011
Results First Received: September 19, 2010  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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) ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
unchecked 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.
unchecked 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.


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