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

Phase 3TerminatedNCT01853384

Healthpoint252 enrolled

Overview

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.

See Brief Summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

252

Conditions

Venous Ulcer Venous Stasis Ulcer Ulcer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (46)

Unnamed facility

Anderlecht, Belgium

Unnamed facility

Brussels, Belgium

Unnamed facility

Edegen, Belgium

Unnamed facility

Ghent, Belgium

Unnamed facility

Kortrijk, Belgium

Unnamed facility

Brno, Czechia

Unnamed facility

Hradec Králové, Czechia

Unnamed facility

Olomouc, Czechia

Unnamed facility

Pardubice, Czechia

Unnamed facility

Plzen-Bory, Czechia

...and 36 more locations

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 12 Weeks

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.

Time frame: 12 weeks

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.

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

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.

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

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.

Time frame: Baseline and Weekly, over the 12 week treatment period

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.

Time frame: Baseline and Weekly, over the 12 week treatment period