NCT02154087终止2 期
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Healthpoint
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
研究概览
简要总结
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
- •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 ≥ 12 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 or any other component of HP802-247,or known sensitivity to Iodine
- •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, or any participation in a previous HP802-247 trial
- •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 Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
- •Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
- •Current therapy with systemic antibiotics
- •Current systemic therapy with cytotoxic drugs
- •Current therapy with chronic (> 10 days) oral corticosteroids
- •Current therapy with TNFα inhibitors
- •History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
结局指标
主要结局
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
时间窗: Wound fluid samples were to be collected one week after the initial dose of HP802-247.
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point \[i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3\]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
次要结局
未报告次要终点
研究者
研究点 (1)
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