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CompletedNCT00395876TROPICS 1Updated Aug 10, 2010Results posted

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

A Phase 3 interventional study of placebo and tenecteplase in Dysfunctional Central Venous Access Catheters, sponsored by Genentech, Inc.. Completed. Per ClinicalTrials.gov, last updated 2010-08-10.

Sponsored by Genentech, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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).

02

Conditions studied

  • Dysfunctional Central Venous Access Catheters

Keywords

  • TNKase
  • CVA
  • CVAD
  • Central venous access catheter
  • CVA catheter
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 10 kg) withdrawn from the selected study CVC following patient repositioning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
  • At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
  • Known hypersensitivity to tenecteplase or any component of the formulation
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Placebo + Tenecteplase + Tenecteplase (PTT)

    Drug: placebo · Drug: tenecteplase

  • Experimental
    Tenecteplase + Tenecteplase + Placebo (TTP)

    Drug: placebo · Drug: tenecteplase

Interventions

  • Drugplacebo

    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).

  • Drugtenecteplase

    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).

06

What researchers measure

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.

    Time frame: 120 minutes after first dose

Secondary outcomes

  1. Percentage of Patients Who Had Restoration of 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.

    Time frame: 15 minutes after first dose

  2. Percentage of Patients Who Had Restoration of 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.

    Time frame: 30 minutes after first dose

  3. Percentage of Patients Who Had Restoration of CVC Function Following a Second 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.

    Time frame: 15 minutes after second dose

  4. Percentage of Patients Who Had Restoration of CVC Function Following a Second 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.

    Time frame: 30 minutes after second dose

  5. Percentage of Patients Who Had Restoration of CVC Function Following a Second 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.

    Time frame: 120 minutes after second dose

  6. Percentage of Patients Who Had Restoration of CVC Function Following a Third 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.

    Time frame: 15 minutes after third dose

  7. Percentage of Patients Who Had Restoration of CVC Function Following a Third 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.

    Time frame: 30 minutes after third dose

  8. Percentage of Patients Who Had Restoration of CVC Function Following a Third 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.

    Time frame: 120 minutes after third dose

  9. Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase

    Restoration of CVC function was defined as the 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.

    Time frame: Up to 120 minutes post-treatment

  10. Percentage of Patients Who Had Restoration 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

    Restoration of CVC function was defined as the 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.

    Time frame: Up to 7 days post-treatment

07

Results

Posted Aug 10, 2010

Participant flow

Participant flow — Overall Study
MilestonePlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Started5050
Completed4750
Not completed30

Outcome measures

PrimaryPercentage 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.

Time frame:
120 minutes after first dose
Reported as:
Number · percentage of participants
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug
percentage of participantsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug23.460.0
Statistical analysis
  • Placebo + Tenecteplase + Tenecteplase (PTT) vs Tenecteplase + Tenecteplase + Placebo (TTP) · Cochran-Mantel-Haenszel · p = 0.0002 (Stratified by baseline weight (\< 30 kg, ≥ 30 kg)) · Mean difference (final values): 36.6 · 95% CI 18.4 to 54.8
SecondaryPercentage of Patients Who Had Restoration of 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.

Time frame:
15 minutes after first dose
Reported as:
Number · percentage of participants
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
percentage of participantsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug10.622.0
Statistical analysis
  • Placebo + Tenecteplase + Tenecteplase (PTT) vs Tenecteplase + Tenecteplase + Placebo (TTP) · Cochran-Mantel-Haenszel · p = 0.1385 (Stratified by baseline weight (\< 30 kg, ≥ 30 kg)) · Mean difference (final values): 11.4 · 95% CI -3.1 to 25.8
SecondaryPercentage of Patients Who Had Restoration of 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.

Time frame:
30 minutes after first dose
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug19.144.0
Statistical analysis
  • Placebo + Tenecteplase + Tenecteplase (PTT) vs Tenecteplase + Tenecteplase + Placebo (TTP) · Cochran-Mantel-Haenszel · p = 0.0093 (Stratified by baseline weight (\< 30 kg, ≥ 30 kg)) · Mean difference (final values): 24.9 · 95% CI 7.1 to 42.6
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Second 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.

Time frame:
15 minutes after second dose
Reported as:
Number · percentage of participants
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
percentage of participantsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug42.6 (28.4 to 56.7)70.0 (57.3 to 82.7)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Second 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.

Time frame:
30 minutes after second dose
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug63.8 (50.1 to 77.6)82.0 (71.4 to 92.6)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Second 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.

Time frame:
120 minutes after second dose
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug72.3 (59.6 to 85.1)88.0 (79.0 to 97.0)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Third 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.

Time frame:
15 minutes after third dose
Reported as:
Number · percentage of participants
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
percentage of participantsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug83.0 (72.2 to 93.7)88.0 (79.0 to 97.0)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Third 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.

Time frame:
30 minutes after third dose
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug85.1 (74.9 to 95.3)88.0 (79.0 to 97.0)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following a Third 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.

Time frame:
120 minutes after third dose
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug85.1 (74.9 to 95.3)88.0 (79.0 to 97.0)
SecondaryPercentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase

Restoration of CVC function was defined as the 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.

Time frame:
Up to 120 minutes post-treatment
Reported as:
Number · percentage of participants
Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase
percentage of participantsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Through first tenecteplase instillation72.3 (59.6 to 85.1)60.0 (46.4 to 73.6)
Through second tenecteplase instillation85.1 (74.9 to 95.3)88.0 (79.0 to 97.0)
SecondaryPercentage of Patients Who Had Restoration 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

Restoration of CVC function was defined as the 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.

Time frame:
Up to 7 days post-treatment
Reported as:
Number · Percentage of patients
Percentage of Patients Who Had Restoration 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
Percentage of patientsPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Percentage of Patients Who Had Restoration 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 Tenecteplase81.5 (66.8 to 96.1)79.3 (64.6 to 94.1)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Tenecteplase + Tenecteplase (PTT)—1/47 (2.1%)6/47 (12.8%)
Tenecteplase + Tenecteplase + Placebo (TTP)—2/50 (4%)14/50 (28%)
Most frequent serious events
Most frequent serious events
EventPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
Mental Status ChangesPsychiatric disorders1/470/50
PancytopeniaBlood and lymphatic system disorders0/471/50
Venous ThrombosisVascular disorders0/471/50
Most frequent other events
Showing 10 of 45
Most frequent other events
EventPlacebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)
VomitingGastrointestinal disorders0/472/50
Catheter Site PainGeneral disorders0/472/50
DizzinessNervous system disorders0/472/50
TachycardiaCardiac disorders1/470/50
DiarrhoeaGastrointestinal disorders1/471/50
PyrexiaGeneral disorders1/470/50
Back PainMusculoskeletal and connective tissue disorders1/470/50
Musculoskeletal PainMusculoskeletal and connective tissue disorders1/470/50
Neck PainMusculoskeletal and connective tissue disorders1/470/50
Pain in ExtremityMusculoskeletal and connective tissue disorders1/470/50

Baseline characteristics

Age, Customized
Age, Customized(participants)Placebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)Total
< 2 years134
≥ 2 to < 17 years141630
≥ 17 to < 65 years172037
≥ 65 years151126
Age Continuous
Age Continuous(years)Placebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)Total
Mean42.2 ± 28.337.1 ± 26.639.6 ± 27.4
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + Tenecteplase + Tenecteplase (PTT)Tenecteplase + Tenecteplase + Placebo (TTP)Total
Female312657
Male162440
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 21111365 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00395876
Lead sponsor
Genentech, Inc.
First posted
Nov 6, 2006
Start date
Nov 2006
Primary completion
Jun 2008
Results posted
Aug 10, 2010
Last update
Aug 10, 2010

Study contacts

Richard Levine, M.D.
study director
View the source record on ClinicalTrials.gov ↗

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