Deep Vein ThrombosisPhase 2MAX-DVTNCT00428129
Microplasmin Administered Via the Trellis-8 Infusion System for Treatment of Acute Iliofemoral DVT
A Phase 2 study testing microplasmin in people with Deep Vein Thrombosis, run by ThromboGenics at 1 site in Ireland.
Trial summary
A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- microplasmin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2007to Oct 2008
- 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
Who may be able to join
- Patients with radiographically-confirmed acute proximal DVT
Who cannot join
- Isolated calf or popliteal vein DVT, based on duplex ultrasound
- Thrombus involving the inferior vena cava (IVC)
- Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound.
- Cannot traverse the target vessel segment with guidewire
- Symptomatic pulmonary embolism is present at time of presentation
- Documented history of prior DVT in target extremity
Show all 17Show fewer
- History of anticoagulants administered for > 30 days for undocumented/ unclear reason (e.g. for reasons other than presence of mechanical cardiac valve, atrial fibrillation, etc.)
- Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
- Cannot receive standard secondary prevention pharmacotherapy [i.e. heparin or LMWH and vitamin K antagonists (VKA)] due to contraindications to anticoagulation [e.g. known bleeding diathesis, thrombocytopenia (platelets < 100,000 mm3), heparin induced thrombocytopenia (HIT), known allergy to heparin or warfarin]
- Absolute contraindication to thrombolytic therapy
- Previous central nervous system haemorrhage
- Life expectancy less than 1 year, due to other comorbid condition.
- Previous intervention in target limb to address venous thrombus.
- Target limb has chronic venous insufficiency of C4 or greater severity
- Acute or chronic symptomatic musculoskeletal condition in target limb (e.g. trauma, fracture, severe arthritis).
- Documented patent foramen ovale or other right-to-left cardiac shunt.
- Absolute contraindication to contrast media or renal insufficiency (baseline creatinine >2.0 mg/dL).
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road
Galway, Co Galway
About this study
Official title: An Open Label Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis
A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT
- Conditions
- Deep Vein Thrombosis
- Being tested
- microplasmin
- Keywords
- Acute Iliofemoral Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microplasminDrug
20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: microplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
Measured: During intervention procedure
Secondary outcomes (4)
Grade of lysis
Measured: Upon completion of procedure
Limb patency
Measured: Baseline, 48h post procedure, Day-7 and Day-30
Target limb reintervention
Measured: Day-7 and Day-30
Clinical outcomes
Measured: Baseline, 48h post procedure, Day-7 and Day-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionOct 2008
Why it stopped: Sponsor's decision to not pursue uPLi for vascular conditions including DVT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bacchus Vascular
- Responsible party
- Sponsor
- Investigators
- Gerard O'Sullivan, MD, Principal investigator, Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428129
- Sponsor's protocol ID
- TG-M-005
- Acronym
- MAX-DVT
- Status last verified
- Apr 2014
- First submitted
- 26 Jan 2007
- 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 Clinical Trial of Microplasmin Administered Via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00428129
- Acronym / sponsor ID
- MAX-DVT / TG-M-005
- Conditions
- Deep Vein Thrombosis
- Keywords
- Acute Iliofemoral Deep Vein Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to not pursue uPLi for vascular conditions including DVT.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Collaborators
- Bacchus Vascular
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Jan 2007 (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.
A single centre, single-arm study to evaluate safety and efficacy of microplasmin administration via the Trellis-8 Infusion System in patients with acute iliofemoral DVT
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: microplasmin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with radiographically-confirmed acute proximal DVT
Key exclusion criteria (17 listed)
- Isolated calf or popliteal vein DVT, based on duplex ultrasound
- Thrombus involving the inferior vena cava (IVC)
- Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound.
- Cannot traverse the target vessel segment with guidewire
- Symptomatic pulmonary embolism is present at time of presentation
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 |
|---|---|---|
| microplasmin20mg with Trellis-8 15cm Treatment length 40mg with Trellis-8 30cm Treatment length | Drug | 1 |
Primary outcome
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin
Time frame: During intervention procedure
4 secondary outcomes
Grade of lysis
Time frame: Upon completion of procedure
Limb patency
Time frame: Baseline, 48h post procedure, Day-7 and Day-30
Target limb reintervention
Time frame: Day-7 and Day-30
Clinical outcomes
Time frame: Baseline, 48h post procedure, Day-7 and Day-30
Results and safety
The study was stopped early (reason given: Sponsor's decision to not pursue uPLi for vascular conditions including DVT.). 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.
Gerard O'Sullivan, MD principal investigator
Section of Interventional Radiology, Department of Radiology, University College Hospital, Newcastle Road, Galway
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 Deep Vein Thrombosis, run by ThromboGenics at 1 site in Ireland.
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 1 inclusion and 17 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 Ireland. 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 to not pursue uPLi for vascular conditions including DVT.). 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?
Treatment success - treated segment has < 25% residual thrombus AND flow is present following administration of microplasmin (time frame: During intervention procedure). 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.