NL-OMON54663招募中2 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 / CUV040
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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.
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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