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Venous UlcerPhase 3NCT01853384

Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

A Phase 3 study testing HP802-247 in people with Venous Ulcer and Venous Stasis Ulcer, run by Healthpoint at 46 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Ulcer, Venous Stasis Ulcer, Ulcer
What is being tested?
HP802-247
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
46 sitesin 5 countries
Study dates
Nov 2013to Feb 2015
Phase
Phase 3
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 ≥ 2.0 cm2 and ≤ 12.0 cm2
  • Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
  • Arterial supply adequacy confirmed
Show all 9Show fewer
  • Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
  • Target ulcer duration ≥ 6 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.
  • 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.
  • 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.
Show all 9Show fewer
  • Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
  • History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
  • Any prior exposure to HP802-247 or its vehicle.

Trial locations and contacts

46 sites in 5 countries.

46 sites in 5 countries

Germany15 sites

  • Study site

    Bochum

  • Study site

    Bonn

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Düsseldorf

  • Study site

    Essen

  • Study site

    Freiburg im Breisgau

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Hamburg

  • Study site

    Kiel

  • Study site

    Krefeld

  • Study site

    Magdeburg

  • Study site

    München

  • Study site

    Münster

Other trials in Germany

Poland10 sites

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Rzeszów

  • Study site

    Studzionka

  • Study site

    Warsaw

  • Study site

    Wroclaw

  • Study site

    Zabrze

Other trials in Poland

Czechia9 sites

  • Study site

    Brno

  • Study site

    Hradec Králové

  • Study site

    Olomouc

  • Study site

    Pardubice

  • Study site

    Plzen-Bory

  • Study site

    Prague

  • Study site

    Třebíč

  • Study site

    Uherské Hradiště

  • Study site

    Ústí nad Labem

Other trials in Czechia

Hungary7 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Hatvan

  • Study site

    Orosháza

  • Study site

    Sátoraljaújhely

  • Study site

    Szeged

  • Study site

    Szolnok

Other trials in Hungary

Belgium5 sites

  • Study site

    Anderlecht

  • Study site

    Brussels

  • Study site

    Edegen

  • Study site

    Ghent

  • Study site

    Kortrijk

Other trials in Belgium

About this study

Official title: A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

Read the detailed description

See Brief Summary

Being tested
HP802-247, HP802-247 Vehicle
Keywords
Venous leg ulcer, ulcer, venous stasis, compression, venous, venous stasis ulcer, vlu, wound, varicose veins, venous insufficiency, dvt, deep vein thrombosis
Medical subject headings
Varicose Ulcer, Ulcer, Wounds and Injuries, Varicose Veins, Venous Insufficiency, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HP802-247Biological

    Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

  • HP802-247 VehicleOther

    Also called Placebo

    HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Study groups in NCT01853384
Study groupRoleWhat they receive
HP802-247 plus compression therapyExperimentalHP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
Receives: Biological: HP802-247
HP802-247 Vehicle plus compression therapyPlacebo comparatorfibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly.
Receives: Other: HP802-247 Vehicle

What is being measured

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

  1. Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

    For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.

    For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

    Measured: Weekly, over 12 Weeks or until wound closure, which ever occurred first

Secondary outcomes (6)

  1. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Cox Proportional Hazard Analysis.

    Measured: 12 Weeks

  2. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.

    This key secondary outcome was based on a Kaplan-Meier Survival analysis.

    Measured: 12 weeks

  3. Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline

    For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.

    Measured: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

  4. Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

    Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.

    Measured: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.

  5. Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks

    Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

    Measured: Baseline and Weekly, over the 12 week treatment period

  6. Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

    Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.

    Measured: Baseline and Weekly, over the 12 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2014
  4. Study completionFeb 2015

Why it stopped: based on outcome of trial NCT01656889.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853384
Sponsor's protocol ID
802-247-09-032
Other IDs
2012-003286-18
Status last verified
Sep 2016
First submitted
8 May 2013
Last updated
3 Oct 2016
Data monitoring committee
Yes

Publications

  • Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.

    PubMed 29037354

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HP802-247 in people with Venous Ulcer and Venous Stasis Ulcer, run by Healthpoint at 46 sites in 5 countries.

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 9 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 46 sites in Germany, Poland, Czechia, Hungary, 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (time frame: Weekly, over 12 Weeks or until wound closure, which ever occurred first). 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 NCT01853384, which also lists 1 linked publication.

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.

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