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Arterial Occlusive DiseasesPhase 1PRIORITYNCT00418483

A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

A Phase 1 study testing Plasmin (Human) 25 mg, Plasmin (Human) 50 mg and Plasmin (Human) 75 mg in people with Arterial Occlusive Diseases, run by Grifols Therapeutics LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arterial Occlusive Diseases
What is being tested?
Plasmin (Human) 25 mg, Plasmin (Human) 50 mg and Plasmin (Human) 75 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteUnited States
Study dates
Mar 2007to Apr 2010
Phase
Phase 1
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

  • Age ≥ 18 years.
  • Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry.
  • Unilateral limb ischemia: SVS acute ischemia Category I or IIa.
  • Onset of symptoms </= 14 days.
  • Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, only occlusions of ≥ 10 cm in length are eligible.
  • Diagnosis of occlusive thrombus in the graft or artery by arteriography after Informed Consent is obtained.
  • Ability to traverse the thrombus with a guidewire.
  • Signed informed consent prior to study entry.

Who cannot join

  • Clinical evidence of significant disease that may interfere with the patient successfully completing the trial.
  • Women who are pregnant or lactating, or first 10 days post-partum.
  • Previous hemorrhagic stroke at any time. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack (TIA)) within one year.
  • Intracranial or spinal neuro-surgery, or severe intracranial trauma in the last 3 months. Major surgery, organ biopsy, or major trauma within the last 10 days. Lumbar puncture or non-compressible arterial puncture in the last 10 days. Intra-ocular surgery within the last 10 days.
  • Current bleeding diathesis. Active gastrointestinal or organ bleeding. Minor bleeding such as normal menses, cystitis, or minor hemorrhoidal bleeding are not exclusions.
  • Uncontrolled arterial hypertension, defined as a systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg.
Show all 15Show fewer
  • Known intracranial neoplasm, aneurysm, or arterio-venous malformation.
  • Platelet count < 75 x 10e9/L.
  • Occlusion of a graft within 6 months of placement.
  • Medically unable to tolerate an open vascular procedure.
  • Known prothrombotic condition.
  • Hemoglobin <10.0 g/dL
  • Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine > 2.0 mg/dL or subjects on renal dialysis.
  • Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days, for example, abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®).
  • Treatment with warfarin (Coumadin®) and with an INR of >1.7 (elevated INR at screening may be corrected prior to study enrollment.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jobst Vascular Institute

    Toledo, Ohio, 43606

Other trials in United States

About this study

Official title: A Sequential Phase I/II Dose Escalation and Dose Selection Safety Study of Regional Intra-thrombus Plasmin (Human) Infusion In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.

Read the detailed description

There is an unmet need for proven thrombolytic agent in acute peripheral arterial occlusion (aPAO). The current assortment of plasminogen activators are slow to dissolve clots in the leg, and may lead to bleeding complications. Plasmin is a direct thrombolytic that may act more quickly when infused directly into the clot and thus assist in restoring blood flow to the leg. There is a large reserve in blood alpha-2 antiplasmin in the blood to rapidly inactivate Plasmin outside of the clot. Plasmin has the potential for an improved bleeding risk profile in aPAO.

Being tested
Plasmin (Human) 25 mg, Plasmin (Human) 50 mg, Plasmin (Human) 75 mg, Plasmin (Human) 100 mg, Plasmin (Human) 125 mg
Keywords
thrombolytic, thrombolysis, acute peripheral arterial occlusion, peripheral vascular disease, thrombosis, endovascular
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.

  • Plasmin (Human) 25 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

  • Plasmin (Human) 50 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

  • Plasmin (Human) 75 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

  • Plasmin (Human) 100 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 100 mg

  • Plasmin (Human) 125 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

  • Plasmin (Human) 150 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

  • Plasmin (Human) 175 mgBiological

    Also called TAL-05-00018, BAY-57-9602

    Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Study groups in NCT00418483
Study groupRoleWhat they receive
Plasmin (Human) 25 mgExperimentalPlasmin (Human) 25 mg
Receives: Biological: Plasmin (Human) 25 mg
Plasmin (Human) 50 mgExperimentalPlasmin (Human ) 50 mg
Receives: Biological: Plasmin (Human) 50 mg
Plasmin (Human) 75 mgExperimentalPlasmin (Human) 75 mg
Receives: Biological: Plasmin (Human) 75 mg
Plasmin (Human) 100 mgExperimentalPlasmin (Human) 100 mg
Receives: Biological: Plasmin (Human) 100 mg
Plasmin (Human) 125 mgExperimentalPlasmin (Human) 125 mg
Receives: Biological: Plasmin (Human) 125 mg
Plasmin (Human) 150 mgExperimentalPlasmin (Human) 150 mg
Receives: Biological: Plasmin (Human) 150 mg
Plasmin (Human) 175 mgExperimentalPlasmin (Human) 175 mg
Receives: Biological: Plasmin (Human) 175 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thrombolysis

    Thrombolysis at the end of treatment compared to baseline by arteriography

    Measured: Approximately 5 hours after start of treatment

Secondary outcomes (7)

  1. Thrombolysis

    Thrombolysis at 120 minutes compared to baseline by arteriography

    Measured: Approximately 2 hours after start of treatment

  2. Avoidance of open surgical procedures

    Percent of subjects at Day 30 who avoid open surgical procedures

    Measured: 30 days

  3. Avoidance of amputation

    Percent of subjects at Day 30 who avoid amputation

    Measured: 30 days

  4. Avoidance of additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy

    Percent of subjects at Day 30 who avoided additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy.

    Measured: 30 days

  5. Avoidance of both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.

    Percent of subjects at Day 30 who avoided both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.

    Measured: 30 days

  6. Physiologic reperfusion defined as improvement in ankle brachial index (ABI)

    Physiologic reperfusion defined as improvement in ABI (increase of ≥ 0.15) determined at the end of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30.

    Measured: End of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30

  7. Patency assessed by duplex ultrasound imaging

    Patency assessed by duplex ultrasound imaging on the affected leg on Day 7 and Day 30

    Measured: 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.

  1. First posted4 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00418483
Sponsor's protocol ID
050003
Acronym
PRIORITY
Status last verified
Oct 2016
First submitted
2 Jan 2007
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Plasmin (Human) 25 mg, Plasmin (Human) 50 mg and Plasmin (Human) 75 mg in people with Arterial Occlusive Diseases, run by Grifols Therapeutics LLC 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 8 inclusion and 15 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 31 Oct 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Thrombolysis (time frame: Approximately 5 hours after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00418483.

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 31 Oct 2016.

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