ThrombosisPhase 3NCT00322270
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
A Phase 3 study testing Alfimeprase in people with Thrombosis and Venous Thrombosis, run by ARCA Biopharma, Inc. at 18 sites in United States.
Trial summary
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Venous Thrombosis, Catheter Occlusion
- What is being tested?
- Alfimeprase
- How many people
- Not given
- Where
- 18 sitesUnited States
- Study dates
- Jan 2006to not given
- 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
- Ages 18 or older
- Unable to withdraw at least 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 or pheresis
- Previous treatment with plasminogen activator for current episode of catheter occlusion
- Less than 18 years of age
- Any evidence of mechanical or nonthrombotic occlusion
Show all 12Show fewer
- 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
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Bethesda Research Center
Boynton Beach, Florida, 33435
Pasco Hernando Oncology Associates
Brooksville, Florida, 34613
Gabrail Cancer Center
Canton, Ohio, 44718
Desert Oasis Cancer Center
Casa Grande, Arizona, 85222
Hematology/Oncology Consultants, Inc.
Columbus, Ohio, 43235
Texas Oncology, P.A.
Dallas, Texas, 75230
Dakota Cancer Institute
Fargo, North Dakota, 58103
Medical and Surgical Specialists
Galesburg, Illinois, 61401
Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, 49048
Sparrow Cancer Center
Lansing, Michigan, 48912
Mercy Hospital
Miami, Florida, 33133
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Pasco Hernando Oncology Associate
New Port Richey, Florida, 34652
Cancer Center at Blessing Hospital
Quincy, Illinois, 62301
Carilion Gynecology/Oncology
Roanoke, Virginia, 24074
Cancer Research & Prevention Center
Soquel, California, 95073
The Center for Cancer Care and Research
St Louis, Missouri, 63141
About this study
Official title: Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.
Read the detailed description
Further study details as provided by Nuvelo
- Conditions
- Thrombosis, Venous Thrombosis, Catheter Occlusion
- Being tested
- Alfimeprase
- Keywords
- Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters
- 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
single-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
Measured: up to120 minutes post study drug dosing
Secondary outcomes (2)
Adverse events, serious adverse events and bleeding events
Measured: 24 hours post dosing
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
Measured: approximately 28-45 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startJan 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan Begelman, M.D., Study director, ARCA Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322270
- Sponsor's protocol ID
- HA008
- Status last verified
- Aug 2008
- First submitted
- 3 May 2006
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Multinational, Open-Label Study to Evaluate the Safety and Efficacy of Alfimeprase in Subjects With Occluded Central Venous Access Devices (SONOMA-3)
- ClinicalTrials.gov ID
- NCT00322270
- Acronym / sponsor ID
- HA008
- Conditions
- Thrombosis, Venous Thrombosis, Catheter Occlusion
- Keywords
- Occluded Central Venous Access Devices, Occluded Catheters, Thrombosis, thrombosis, catheter, alfimeprase, thrombotic occlusion, thrombosis, CVAD, thrombosis, catheters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 5 May 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.
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central venous access device.
Detailed description
Further study details as provided by Nuvelo
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must give written informed consent
- Ages 18 or older
- Unable to withdraw at least 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 or pheresis
- Previous treatment with plasminogen activator for current episode of catheter occlusion
- Less than 18 years of age
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 |
|---|---|---|
| Alfimeprasesingle-dose of alfimeprase, 10 mg.administered intracatheter to an occluded CVAD | Drug | – |
Primary outcome
Safety and efficacy
Time frame: up to120 minutes post study drug dosing
2 secondary outcomes
Adverse events, serious adverse events and bleeding events
Time frame: 24 hours post dosing
Adverse events up to day 30 visit(day 28-45) after instillation of study drug
Time frame: approximately 28-45 days post dosing
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 15 Aug 2008.
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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.
Susan Begelman, M.D. study director
ARCA Biopharma, Inc.
18 sites 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 18 sites 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 5 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 15 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 18 sites 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?
Safety and efficacy (time frame: up to120 minutes post study drug dosing). 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 15 Aug 2008.