ThrombosisPhase 3NCT00346424
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
A Phase 3 study testing Alfimeprase in people with Thrombosis and Venous Thrombosis, run by ARCA Biopharma, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Venous Thrombosis
- What is being tested?
- Alfimeprase
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent
- Unable to withdraw 3 mL of blood from a central venous access device
- Hemodynamically stable
- Available for follow-up assessments
Who cannot join
- Inability to infuse at least 2 mL of saline through the catheter
- Catheter placed less than 48 hours prior to detection of occlusion
- Catheter used for hemodialysis of pheresis
- Less than 18 years of age
- Evidence of mechanical or nonthrombotic occlusion
- Receipt of any thrombolytic agent within 24 hours of randomization
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- In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
- Increased risk for drug extravasation
- Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
- Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
- Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
- Any other subject feature that in the opinion of the investigator should preclude study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
Read the detailed description
Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.
Secondary Outcomes:
The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.
Safety:
- Adverse events
- Major bleeding events
- Change in laboratory values.
- Conditions
- Thrombosis, Venous Thrombosis
- Being tested
- Alfimeprase
- Keywords
- occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis
- Medical subject headings
- Thrombosis, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfimepraseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter function restoration at fifteen minutes after initial instillation of study drug.
Measured: 15 minutes
Secondary outcomes (2)
Catheter function restoration at 30 minutes after initial instillation of study drug.
Measured: 30 minutes
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.
Measured: additional 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startSep 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Deitcher, M.D., Study director, ARCA Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346424
- Sponsor's protocol ID
- HA006
- Status last verified
- Aug 2008
- First submitted
- 28 Jun 2006
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices
- ClinicalTrials.gov ID
- NCT00346424
- Acronym / sponsor ID
- HA006
- Conditions
- Thrombosis, Venous Thrombosis
- Keywords
- occluded central catheter, central venous access devices dysfunction, withdrawal occlusion, Thrombosis, Venous thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Jun 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.
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
Detailed description
Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.
Secondary Outcomes:
The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.
Safety:
- Adverse events
- Major bleeding events
- Change in laboratory values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must give written informed consent
- Unable to withdraw 3 mL of blood from a central venous access device
- Hemodynamically stable
- Available for follow-up assessments
Key exclusion criteria (12 listed)
- Inability to infuse at least 2 mL of saline through the catheter
- Catheter placed less than 48 hours prior to detection of occlusion
- Catheter used for hemodialysis of pheresis
- Less than 18 years of age
- Evidence of mechanical or nonthrombotic occlusion
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 |
|---|---|---|
| Alfimeprase | Drug | – |
Primary outcome
Catheter function restoration at fifteen minutes after initial instillation of study drug.
Time frame: 15 minutes
2 secondary outcomes
Catheter function restoration at 30 minutes after initial instillation of study drug.
Time frame: 30 minutes
Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose.
Time frame: additional 30 minutes
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 14 Aug 2008.
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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.
Steven Deitcher, M.D. study director
ARCA Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfimeprase in people with Thrombosis and Venous Thrombosis, run by ARCA Biopharma, Inc. at 1 site in United States.
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 4 inclusion and 12 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 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
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?
Catheter function restoration at fifteen minutes after initial instillation of study drug. (time frame: 15 minutes). 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 14 Aug 2008.