Arterial Occlusive DiseasesPhase 2NCT00073554
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion
A Phase 2 study testing Alfimeprase in people with Arterial Occlusive Diseases and Peripheral Vascular Diseases, run by ARCA Biopharma, Inc. at 1 site in United States.
Trial summary
This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis
- What is being tested?
- Alfimeprase
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to not given
- Phase
- Phase 2
- 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
- Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days)
- Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow)
- Age 18 or above
- Able to consent
- Able to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).
- Being tested
- Alfimeprase
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfimepraseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2003 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073554
- Sponsor's protocol ID
- HA002
- Other IDs
- NAPA-1
- Status last verified
- Nov 2006
- First submitted
- 24 Nov 2003
- Last updated
- 17 Dec 2009
- Results posted
- No
Publications
Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.
PubMed 11910179
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
- ClinicalTrials.gov ID
- NCT00073554
- Acronym / sponsor ID
- HA002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Jun 2003
- First posted
- 26 Nov 2003 (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 trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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
Not reported in the source record.
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 17 Dec 2009.
- Background: PubMed 11910179Toombs CF. Alfimeprase: pharmacology of a novel fibrinolytic metalloproteinase for thrombolysis. Haemostasis. 2001 May-Dec;31(3-6):141-7. doi: 10.1159/000048057.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alfimeprase in people with Arterial Occlusive Diseases and Peripheral Vascular Diseases, 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?
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 17 Dec 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073554, 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 17 Dec 2009.