EUCTR2008-002446-39-FR进行中（未招募）1 期
A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoing Photodynamic Therapy (PDT) utilising Porfimer Sodium - Phase II PDT Pilot Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Male or female Caucasian subjects undergoing PDT with porfimer sodium.
- •Aged greater than 18 years
- •Fitzpatrick Skin Type I- IV
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known allergy or hypersensitivity to CUV1647 or the polymer contained in the implant
- •Non-Caucasian patients
- •Personal history of melanoma or dysplastic nevus syndrome
- •Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions
- •Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating
- •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device)
- •Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit
- •Patients unable to give informed consent
- •Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
研究者
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