Dysfunctional Central Venous Access CathetersPhase 3TROPICS 1NCT00395876
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
A Phase 3 study testing tenecteplase in people with Dysfunctional Central Venous Access Catheters, run by Genentech, Inc..
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysfunctional Central Venous Access Catheters
- What is being tested?
- tenecteplase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 10 kg) withdrawn from the selected study CVC following patient repositioning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)
Show all 17Show fewer
- 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
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
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).
- Being tested
- placebo, tenecteplase
- Keywords
- TNKase, CVA, CVAD, Central venous access catheter, CVA catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
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).
tenecteplaseDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Tenecteplase + Tenecteplase (PTT) | Placebo comparator | Not described Receives: Drug: placebo; Drug: tenecteplase |
| Tenecteplase + Tenecteplase + Placebo (TTP) | Experimental | Not described Receives: Drug: placebo; Drug: tenecteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes after first dose
Secondary outcomes (10)
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.
Measured: 15 minutes after first dose
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.
Measured: 30 minutes after first dose
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.
Measured: 15 minutes after second dose
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.
Measured: 30 minutes after second dose
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.
Measured: 120 minutes after second dose
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.
Measured: 15 minutes after third dose
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.
Measured: 30 minutes after third dose
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.
Measured: 120 minutes after third dose
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.
Measured: Up to 120 minutes post-treatment
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.
Measured: Up to 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Central Venous Access CathetersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Levine, M.D., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395876
- Sponsor's protocol ID
- N3698g
- Acronym
- TROPICS 1
- Status last verified
- Jul 2010
- First submitted
- 2 Nov 2006
- Last updated
- 10 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
- ClinicalTrials.gov ID
- NCT00395876
- Acronym / sponsor ID
- TROPICS 1 / N3698g
- Keywords
- TNKase, CVA, CVAD, Central venous access catheter, CVA catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Posted 10 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Tenecteplase + Tenecteplase (PTT) | Placebo comparator | Drug: placebo, Drug: tenecteplase |
| Tenecteplase + Tenecteplase + Placebo (TTP) | Experimental | Drug: placebo, Drug: tenecteplase |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo2 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 | Placebo + Tenecteplase + Tenecteplase (PTT), Tenecteplase + Tenecteplase + Placebo (TTP) |
| tenecteplase2 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). | Drug | Placebo + Tenecteplase + Tenecteplase (PTT), Tenecteplase + Tenecteplase + Placebo (TTP) |
Primary outcome
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug
Time frame: 120 minutes after first dose
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.
10 secondary outcomes
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
Time frame: 15 minutes after first dose
Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
Time frame: 30 minutes after first dose
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
Time frame: 15 minutes after second dose
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
Time frame: 30 minutes after second dose
Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
Time frame: 120 minutes after second dose
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
Time frame: 15 minutes after third dose
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
Time frame: 30 minutes after third dose
Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
Time frame: 120 minutes after third dose
Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase
Time frame: Up to 120 minutes post-treatment
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
Time frame: Up to 7 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21111365Gabrail 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Levine, M.D. study director
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tenecteplase in people with Dysfunctional Central Venous Access Catheters, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug (time frame: 120 minutes after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.