Peripheral Artery DiseasePhase 1NCT02953496
Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries
A Phase 1 study testing vonapanitase in people with Peripheral Artery Disease, run by Proteon Therapeutics at 1 site in United States.
Trial summary
The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- vonapanitase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento 30 Apr 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 years.
- Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
- ABI <0.90 at rest or with exercise, or a toe-brachial index (TBI) <0.70 if ABI value is >1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
- Rutherford category 2-4.
- Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR >2.4.
- De novo lesion, not previously treated by angioplasty, atherectomy, or stent.
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- If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. Acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner.
- Ability to understand and comply with the requirements of the entire study and communicate with the study team.
- Ability to provide written informed consent using a document that has been approved by the required institutional review board.
Who cannot join
- Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g., Buerger's disease, vasculitis).
- Total occlusion of the SFA or PA in the index leg.
- Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
- Deep vein thrombosis within the past 3 months.
- Known bleeding disorder.
- Presence of any arterial aneurysm in the index leg.
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- Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation).
- Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal.
- Arterial systolic BP >200 mmHg or diastolic BP >100 mmHg at screening or day of procedure.
- Pregnancy, lactation or plans to become pregnant during the course of the study.
- Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
- Malignancy or treatment for malignancy within the previous 12 months with the exception localized basal cell or squamous cell skin cancer, or any cancer in situ.
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
- Known allergy to contrast media, iodine, lidocaine, prilocaine, or EMLA Cream (lidocaine 2.5% and prilocaine 2.5%).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Phase 1 Multi-Center, Dose-Escalation Study of Vonapanitase Administered Percutaneously to the Superficial Femoral or Popliteal Artery in Patients With Peripheral Artery Disease
The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
- Conditions
- Peripheral Artery Disease
- Being tested
- vonapanitase
- Keywords
- peripheral artery disease, PAD, vonapanitase, claudication, superficial femoral artery, SFA, popliteal artery, stenosis, elastase, chymotrypsin-like elastase 1, CELA1, PRT-201
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonapanitaseDrug
Also called PRT-201
Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| vonapanitase | Experimental | Not described Receives: Drug: vonapanitase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology tests
Measured: Up to 6 months following study drug administration
Technical success of percutaneous injection
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: Change in operating plans
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953496
- Sponsor's protocol ID
- PRT-201-110
- Status last verified
- Apr 2019
- First submitted
- 26 Oct 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Center, Dose-Escalation Study of Vonapanitase Administered Percutaneously to the Superficial Femoral or Popliteal Artery in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT02953496
- Acronym / sponsor ID
- PRT-201-110
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, PAD, vonapanitase, claudication, superficial femoral artery, SFA, popliteal artery, stenosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in operating plans
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Proteon TherapeuticsIndustry (pharma, biotech, devices)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 2 Nov 2016 (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 research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vonapanitase | Experimental | Drug: vonapanitase |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of at least 18 years.
- Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
- ABI <0.90 at rest or with exercise, or a toe-brachial index (TBI) <0.70 if ABI value is >1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
- Rutherford category 2-4.
- Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR >2.4.
Key exclusion criteria (14 listed)
- Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g., Buerger's disease, vasculitis).
- Total occlusion of the SFA or PA in the index leg.
- Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
- Deep vein thrombosis within the past 3 months.
- Known bleeding disorder.
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 |
|---|---|---|
| vonapanitaseAlso: PRT-201Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance. | Drug | vonapanitase |
Primary outcome
Incidence of adverse events
Time frame: Up to 6 months following study drug administration
Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology tests
Technical success of percutaneous injection
Time frame: Intraprocedural
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
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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 1 study testing vonapanitase in people with Peripheral Artery Disease, run by Proteon Therapeutics 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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of adverse events (time frame: Up to 6 months following study drug administration). The study lists 2 primary outcomes in all. 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 2 May 2019.