A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 447
- 试验地点
- 50
- 主要终点
- Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
时间窗: 12 Weeks
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, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
次要结局
- 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.(12 Weeks)
- Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline(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(Target ulcer status observed at two and three months following initial ulcer closure.)
- Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks(Weekly, over the 12 week treatment period, baseline)
- Change in Target Ulcer Pain(Weekly, over 12 week treament period, baseline)
- Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.(12 weeks)