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

CLINUVEL EUROPE LTD0 个研究点目标入组 6 人开始时间: 2021年7月9日最近更新: 2022年3月28日

适应症

试验速览

暂无简介。

•-Male or female patient with a molecular-genetically confirmed diagnosis of XP-C.
•-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 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•-Known allergy to afamelanotide or the polymer contained in the implant
•-Presence of severe hepatic disease or 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 life-style excluding pregnancy, for up to three months after the last implant administration.
•-Sexually active man with a partner of child-bearing potential (pre-menopausal, 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.

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