RBR-4vz9c4尚未招募3 期
Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacyand Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa
Hospital da Criança Santo Antônio - Irmandade Santa Casa de Misericórdia de Porto Alegre0 个研究点开始时间: 2018年2月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 4Y 至 —（—）
入选标准
- •Male and female patients with any subtype of inherited Epidermolyse bullosa age more than 4 years; Patients with an Epidermolyse bullosa target wound; 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; Patient and/or his/her legal representative must be able and willing to follow study
- •procedures and instructions.
排除标准
- •Epidermolyse bullosa target wound with clinical signs of local infection; Use of systemic antibiotics for wound-related infections within seven days prior to enrolment; Administration of systemic or topical steroids within 30 days before enrolment; Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment; Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB; Current and/or former malignancy; Enrolment in any interventional study or treated with any investigational drug for any
- •disease within 4 weeks prior to study entry; 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; Pregnant or nursing women and women of childbearing potential including postmenarchal female adolescents not willing to use an effective form of birth control
- •(e.g., implant, injectable, combined oral contraceptive, intrauterine contraceptive device, sexual abstinence, vasectomised partner) during participation in the study (and at least 3 months thereafter); Patient is a member of the investigational team or his/her immediate family; Patient lives in the same household as a study participant
研究者
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