Dysfunctional Central Venous Access Devices (CVADS)Phase 4NCT00307580
Cathflo Activase Pediatric Study
A Phase 4 study testing Cathflo Activase (Alteplase) in people with Dysfunctional Central Venous Access Devices (CVADS), run by Genentech, Inc..
Trial summary
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Dysfunctional Central Venous Access Devices (CVADS)
- What is being tested?
- Cathflo Activase (Alteplase)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to May 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects had to meet the following inclusion criteria to be eligible for study entry:
- Less than 17 years of age
- Clinically stable
- Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
- For subjects who weighed >= 10 kg, inability to withdraw 3 mL of blood from the CVAD
- For subjects who weighed < 10 kg, inability to withdraw 1 mL of blood from the CVAD
- Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
- Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study
Who cannot join
- Ability to withdraw blood following subject repositioning
- CVAD insertion < 48 hours prior to enrollment
- Selected study catheter implanted specifically for hemodialysis
- Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
- Previous enrollment in this study
- Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
- At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
- Known hypersensitivity to alteplase or any component of the formulation
About this study
Official title: Cathflo Activase (Alteplase) Pediatric Study (CAPS)
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
- Being tested
- Cathflo Activase (Alteplase)
- Keywords
- CVADS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathflo Activase (Alteplase)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
Secondary outcomes (1)
To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startApr 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Central Venous Access Devices (CVADS)Studies 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 4
- Primary purpose
- Treatment
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martha Blaney, PharmD, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307580
- Sponsor's protocol ID
- A2404g
- Status last verified
- Apr 2014
- First submitted
- 25 Mar 2006
- Last updated
- 9 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathflo Activase (Alteplase) Pediatric Study (CAPS)
- ClinicalTrials.gov ID
- NCT00307580
- Acronym / sponsor ID
- A2404g
- Keywords
- CVADS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- May 2003 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
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 IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Less than 17 years of age
- Clinically stable
- Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
- For subjects who weighed >= 10 kg, inability to withdraw 3 mL of blood from the CVAD
- For subjects who weighed < 10 kg, inability to withdraw 1 mL of blood from the CVAD
Key exclusion criteria (8 listed)
- Ability to withdraw blood following subject repositioning
- CVAD insertion < 48 hours prior to enrollment
- Selected study catheter implanted specifically for hemodialysis
- Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
- Previous enrollment in this 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 |
|---|---|---|
| Cathflo Activase (Alteplase) | Drug | – |
Primary outcome
To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
1 secondary outcome
To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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.
Martha Blaney, PharmD study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cathflo Activase (Alteplase) in people with Dysfunctional Central Venous Access Devices (CVADS), 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 8 inclusion and 8 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 9 Apr 2014. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2014.