Venous Leg UlcersPhase 2MOA 034NCT02154087
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
A Phase 2 study testing HP802-247 in people with Venous Leg Ulcers, run by Healthpoint at 1 site in United States.
Trial summary
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers
- What is being tested?
- HP802-247
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Provide informed consent
- Age ≥ 18 years and of either sex
- Willing to comply with protocol instructions, including allowing all study assessments
- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence
- Arterial supply adequacy confirmed
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- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
- Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months).
- Acceptable state of health and nutrition
Who cannot join
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine
- Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic)
- Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit
- Refusal of or inability to tolerate compression therapy
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- Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
- Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
- Current therapy with systemic antibiotics
- Current systemic therapy with cytotoxic drugs
- Current therapy with chronic (> 10 days) oral corticosteroids
- Current therapy with TNFα inhibitors
- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Trial locations and contacts
1 site in 1 country.
About this study
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
- Conditions
- Venous Leg Ulcers
- Being tested
- HP802-247
- Keywords
- Venous leg ulcer, Ulcer, Venous stasis, Compression
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP802-247Biological
260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
| Study group | Role | What they receive |
|---|---|---|
| HP802-247 | Experimental | Not described Receives: Biological: HP802-247 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
Measured: Wound fluid samples were to be collected one week after the initial dose of HP802-247.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionOct 2015
Why it stopped: based on outcome of previous study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Smith & Nephew Biotherapeutics; Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154087
- Sponsor's protocol ID
- 802-247-09-034
- Acronym
- MOA 034
- Status last verified
- Sep 2016
- First submitted
- 28 May 2014
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02154087
- Acronym / sponsor ID
- MOA 034 / 802-247-09-034
- Conditions
- Venous Leg Ulcers
- Keywords
- Venous leg ulcer, Ulcer, Venous stasis, Compression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: based on outcome of previous study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP802-247 | Experimental | Biological: HP802-247 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide informed consent
- Age ≥ 18 years and of either sex
- Willing to comply with protocol instructions, including allowing all study assessments
- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence
Key exclusion criteria (13 listed)
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine
- Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic)
- Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit
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 |
|---|---|---|
| HP802-247260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle | Biological | HP802-247 |
Primary outcome
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
Time frame: Wound fluid samples were to be collected one week after the initial dose of HP802-247.
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert B Slade, MD study chair
Smith & Nephew Biotherapeutics; Chief Medical Officer
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 HP802-247 in people with Venous Leg Ulcers, run by Healthpoint 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 13 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 3 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 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?
Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 (time frame: Wound fluid samples were to be collected one week after the initial dose of HP802-247.). 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 3 Oct 2016.