Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Study Overview
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Brief Summary
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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). At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Detailed Description
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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 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Official Title
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A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Conditions
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Venous Leg Ulcers

Intervention / Treatment
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* Biological: HP802-247
* Biological: Vehicle


Participation Criteria
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Eligibility Criteria
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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 >12 cm2 to ≤ 36 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP802-247<br>HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days. | Biological: HP802-247<br>* HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle Control(fibrinogen solution & thrombin solution without cells) | Biological: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline. | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Days to Closure | Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline. | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous leg ulcer, ulcer, Venous stasis, compression, venous, venous stasis ulcer, vlu, wound, varicose veins, venous insufficiency, dvt, deep vein thrombosis