EUCTR2018-004164-60-NL进行中（未招募）1 期
A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease. - Phase IIa VP Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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 patients with confirmed diagnosis of VP.
- •Patients with VP-related skin symptoms assessed with a score equal or above 7 on the 11-point VAS IGA.
- •Aged 18-70 years.
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Known allergy to afamelanotide or the polymer or to lignocaine/lidocaine or other local anaesthetic.
- •Had two or more acute attacks of hepatic porphyria lasting more than two days, within 12 months prior to the Screening period.
- •History of certain malignant and premalignant skin lesions.
- •Individual or family history of melanoma.
- •Severe hepatic disease.
- •Renal impairment (eGFR (MDRD) < 30 ml/min*1.73m2).
- •Female who is pregnant or lactating.
- •Females of child-bearing potential not using adequate contraceptive measures.
- •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
- •Not suitable for trial participation in the opinion of the Investigator.
研究者
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