EUCTR2009-011018-51-IE进行中（未招募）不适用
A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP). - Multicentre Phase III EPP Study 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •To be eligible to enter the study, patients must meet the following inclusion criteria:
- •- Male or female subjects with a positive diagnosis of EPP (confirmed by elevated free protoporphyrin in peripheral erythrocytes);
- •- Aged 18-70 years (inclusive); and
- •- Provide written Informed Patient Consent prior to the performance of any study-specific procedure.
- •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
- •To be eligible to enter the study, patients must not meet any of the following exclusion criteria:
- •- Any allergy to afamelanotide or the polymer contained in the implant or to lignocaine or other local anaesthetic to be used during the administration of the study medication;
- •- EPP patients with significant hepatic involvement;
- •- 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;
- •- Any other photodermatosis such as PLE, DLE or solar urticaria;
- •- Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations;
- •- Acute history of drug or alcohol abuse (in the last 12 months);
- •- Patient assessed as not suitable for the study in the opinion of the Investigator (e.g. noncompliance history, allergic to local anaesthetics, faints when given injections or giving blood);
- •- 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);
- •- Sexually active men with partners of child bearing potential not using barrier contraception during the trial and for a period of three months thereafter;
- •- Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit; and
- •- Prior and concomitant therapy with medications which may interfere with the objectives of the study, including drugs that cause photosensitivity or skin pigmentation.
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