Arterial Occlusive DiseasesPhase 2NCT00123292
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
A Phase 2 study testing Microplasmin in people with Arterial Occlusive Diseases, run by ThromboGenics at 1 site in Belgium.
Trial summary
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Microplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2005to Nov 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
- Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
- Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
- Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
Who cannot join
- Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
- Occlusion not penetrable by the infusion guide wire.
- Known or suspected allergy to contrast agents or heparin sodium.
- Active bleeding or known hemorrhagic diathesis.
- Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
Read the detailed description
This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Microplasmin
- Keywords
- arterial occlusion, thromboembolism, Acute Peripheral Arterial Occlusion
- Medical subject headings
- Arterial Occlusive Diseases, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroplasminDrug
An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
MicroplasminDrug
An infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).
MicroplasminDrug
An infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Microplasmin |
| 2 | Experimental | Not described Receives: Drug: Microplasmin |
| 3 | Experimental | Not described Receives: Drug: Microplasmin |
| 4a | Experimental | Not described Receives: Drug: Microplasmin |
| 4b | Experimental | Not described Receives: Drug: Microplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
Measured: at 4 hours or less (if study drug administration is terminated prior to 4 hours).
Secondary outcomes (1)
Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)
Measured: At 4 hours or less (if study drug administration is terminated prior to 4 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2007
- Study completionNov 2009
Why it stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Verhamme, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123292
- Sponsor's protocol ID
- TG-M-002
- Status last verified
- Apr 2014
- First submitted
- 21 Jul 2005
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
- ClinicalTrials.gov ID
- NCT00123292
- Acronym / sponsor ID
- TG-M-002
- Conditions
- Arterial Occlusive Diseases
- Keywords
- arterial occlusion, thromboembolism, Acute Peripheral Arterial Occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions
- Enrolment
- 19 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Jul 2005 (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 trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
Detailed description
This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Microplasmin |
| 2 | Experimental | Drug: Microplasmin |
| 3 | Experimental | Drug: Microplasmin |
| 4a | Experimental | Drug: Microplasmin |
| 4b | Experimental | Drug: Microplasmin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
- Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
- Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
- Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
Key exclusion criteria (5 listed)
- Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
- Occlusion not penetrable by the infusion guide wire.
- Known or suspected allergy to contrast agents or heparin sodium.
- Active bleeding or known hemorrhagic diathesis.
- Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
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 |
|---|---|---|
| MicroplasminAn infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion). | Drug | 1, 2, 3 |
| MicroplasminAn infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion). | Drug | 4a |
| MicroplasminAn infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered. | Drug | 4b |
Primary outcome
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram)
Time frame: at 4 hours or less (if study drug administration is terminated prior to 4 hours).
1 secondary outcome
Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography)
Time frame: At 4 hours or less (if study drug administration is terminated prior to 4 hours).
Results and safety
The study was stopped early (reason given: Sponsor's decision not to pursue development of uPLi for vascular conditions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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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.
Peter Verhamme, MD, PhD principal investigator
KU Leuven
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 Microplasmin in people with Arterial Occlusive Diseases, run by ThromboGenics at 1 site in Belgium.
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 5 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: stopped early, as of the sponsor's last update on 7 Apr 2014. 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 Belgium. 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 was stopped early (reason given: Sponsor's decision not to pursue development of uPLi for vascular conditions). Results are not available in the source record.
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?
Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram) (time frame: at 4 hours or less (if study drug administration is terminated prior to 4 hours).). 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 7 Apr 2014.