NCT01749306终止3 期
A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 18
- 主要终点
- Reduction in wound surface area
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.
It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or legal guardian must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions
- •Male and female subjects.
- •Stable nutritional status.
- •Subjects with a confirmed diagnosis of generalized Epidermolysis Bullosa (EB)
- •Cutaneous wounds meeting the following criteria:
- •Anatomical location: arms, legs, thorax, or back above the waistline and below the neck.
- •Documented age (duration) of the wound(s).
- •One or more wounds capable of potentially meeting the following wound selection criteria at the end of the observation period:
- •i. Two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.
- •ii. Two matched wounds.
- •Negative urine pregnancy test for women of child-bearing potential.
- •Female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception.
排除标准
- •Pregnant or nursing women.
- •Diagnosis of non-genetic generalized EB.
- •Localized, active clinical infection of study wounds.
- •Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
- •Known allergy to bovine products.
- •Known allergy to silver products.
- •Systemic infection at the time of enrolment in the study.
- •Currently receiving or have received oral steroid therapy within the previous 4 weeks.
- •Taking, or have participated in other clinical studies involving gene therapy, stem cell therapy, recombinant DNA/protein therapy.
- •Received ABH001, or other biologic or cell therapy for the treatment of EB in the study wound sites within the previous 3 months.
- •Hypersensitivity to any of the therapeutic agents.
- •History of malignant skin disease.
结局指标
主要结局
Reduction in wound surface area
时间窗: 24 weeks
次要结局
- Change in wound pain and wound itch(24 weeks)
- Durability of wound healing(24 weeks)
- Clinician global impression of change (CGIC)(24 weeks)
- Proportion of subjects achieving reduction in wound surface area(24 weeks)
- Time to reduction of wound surface area and duration of reduction(24 weeks)
- Incidence, relatedness and severity of adverse events(Up to 48 Weeks)
- Patient global impression of change (PGIC)(24 weeks)
研究者
研究点 (18)
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