EUCTR2019-000597-34-DE进行中（未招募）1 期
A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety andEfficacy of Subcutaneous Implants of Afamelanotide in Patients withXeroderma Pigmentosum (XP) - Phase IIa XP Study
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 patient with a molecular-genetically confirmed
- •diagnosis of XPC.
- •- Aged 18-75 years.
- •- Providing written Informed Consent prior to the performance of any
- •study-specific procedure.
- •- Willing and able to comply with the conditions specified in the
- •protocol and study procedures, in the opinion of the Investigator.
- •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 5
- •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 contained in the
- •implant or to lignocaine/ lidocaine or other local anaesthetic to be used during the administration of the implant, if applicable.
- •- Presence of severe hepatic disease.
- •- Hepatic impairment.
- •- Renal impairment.
- •- Any other medical condition which may interfere with the study protocol.
- •- Existing melanoma
- •- Female who is pregnant (confirmed by positive urine ß-HCG
- •pregnancy test) 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) or a lifestyle excluding pregnancy, for up to three months after the last implant administration.
- •- Sexually active man with a partner of child-bearing potential (premenopausal, not surgically sterile) who is not using adequate
- •contraceptive measures, as described above.
- •- Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening visit.
- •- Participation in a clinical trial for an investigational agent within 30 days prior to the Screening visit.
- •- Not suitable for trial participation in the opinion of the Investigator
研究者
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