Clinical trial NCT01853384: Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
Official title: A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Ulcer
Venous Stasis Ulcer
Ulcer
Keywords: Venous leg ulcer
ulcer
venous stasis
compression
venous
venous stasis ulcer
vlu
wound
varicose veins
venous insufficiency
dvt
deep vein thrombosis
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Detailed description: See Brief Summary

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
timeFrame: Weekly, over 12 Weeks or until wound closure, which ever occurred first
Secondary outcomes:
measure: 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.
timeFrame: 12 Weeks
measure: 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.
timeFrame: 12 weeks
measure: Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
timeFrame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
measure: Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
timeFrame: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.
measure: Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
timeFrame: Baseline and Weekly, over the 12 week treatment period
measure: Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
timeFrame: Baseline and Weekly, over the 12 week treatment period
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
city: Brussels
country: Belgium
city: Edegen
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Plzen-Bory
country: Czech Republic
city: Praha
country: Czech Republic
city: Trebic
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Duesseldorf
country: Germany
city: Essen
country: Germany
city: Freiburg
country: Germany
city: Goettingen
country: Germany
city: Greifswald
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Koeln
country: Germany
city: Krefeld
country: Germany
city: Magdeburg
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Hatvan
country: Hungary
city: Oroshaza
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szeged
country: Hungary
city: Szolnok
country: Hungary
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Rzeszow
country: Poland
city: Studzionka
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
Study officials:
affiliation: Smith & Nephew, Inc.
name: Herbert B. Slade, MD
role: STUDY_CHAIR
affiliation: Smith & Nephew, Inc.
name: Tommy Lee, MSHS
role: STUDY_DIRECTOR
affiliation: University Freiburg-Practice for Dermatology
name: Wolfgang Vanscheidt, Professor Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.