EUCTR2016-002066-32-IE进行中（未招募）1 期
Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study
Amryt Research Limited0 个研究点目标入组 250 人开始时间: 2017年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A patient will be eligible for study participation only if all of the following
- •criteria apply:
- •1. Male and female patients aged =4 years with the following subtypes
- •of inherited EB: JEB, DEB, and Kindler syndrome [Note: Children =21
- •days old and <4 years may be included only after confirmation by the
- •Independent Data Monitoring Committee (IDMC) upon review of the
- •safety and bioanalytical data at the interim safety review stage]
- •2. Patients with an EB target wound (i.e., EB partial thickness wound of
- •10 cm2 to 50 cm2 in size aged =21 days and <9 months) outside of the anogenital region
- •3. Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed
- •consent form, and has/have given written informed consent
- •4. Patient and/or his/her legal representative must be able and willing
- •to follow study procedures and instructions
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 171
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •A patient will not be eligible to participate in this study if any of the
- •following criteria apply:
- •1. Patient has EB subtype EBS
- •2. EB target wound that is > 9 months old or has clinical signs of local
- •3. Use of systemic antibiotics for wound-related infections within 7 days
- •prior to enrolment
- •4. Administration of systemic or topical steroids (except for inhaled,
- •ophthalmic or topical applications, such as budesonide suspension for
- •oesophageal strictures [e.g., Pulmicort Respules® 0.25 mg/2 mL or 0.5
- •mg/2 mL]) within 30 days before enrolment
- •5. Immunosuppressive therapy or cytotoxic chemotherapy within 60
- •days prior to enrolment
- •6. Patient has undergone stem cell transplant or gene therapy for the
- •treatment of inherited EB
- •7. Current and/or former malignancy including basal cell carcinomas and
- •squamous cell carcinomas
- •8. Enrolment in any interventional study or treated with any
- •investigational drug for any disease within 4 weeks prior to study entry
- •9. Factors present in the patient and/or his/her legal representative that
- •could interfere with study compliance such as inability to attend
- •scheduled study visits or compliance with home dressing changes
- •10. Pregnant or nursing women
- •11. Women of childbearing potential, including postmenarchal female
- •adolescents, and men who are not willing to use an effective form of
- •birth control with failure rates <1% per year (e.g., implant, injectable,
- •combined oral contraceptive, intrauterine contraceptive device, sexual
- •abstinence, vasectomy or vasectomised partner) during participation in
- •the study (and at least 3 months thereafter)
- •12.Patient is a member of the investigational team or his/her immediate
- •13.Patient lives in the same household as a study participant.
研究者
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