EUCTR2016-002066-32-GR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5月5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
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 infection
- •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 family
- •13. Patient lives in the same household as a study participant.
研究者
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