Phase IIa Biomarker Study to Evaluate the Efficacy, Safety and Tolerability of AT-1 in Patients with Hereditary Cystatin C Amyloid Angiopathy (HCCAA) - the AT1-HCCAA study

Arctic Therapeutics ehf0 个研究点目标入组 50 人开始时间: 2018年9月19日最近更新: 2019年4月30日

适应症

试验速览

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•Inclusion Criteria
•1Patient is male or female, ages 18 or older, of Icelandic ancestry known to carry the HCCAA mutation L68Q.
•2Patient is judged to be in sufficient medical health to be able to participate in the study.
•3Patient has HCCAA confirmed by mutation status detection of L68Q
•4Patient has been genotyped/sequenced and confirmed to carry the L68Q mutation in the cystatin C gene
•5Patient is willing to have a baseline and follow up skin biopsy every 3 months for up to 9 months.
•6Patient has provided informed consent for participation in trial
•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 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion Criteria
•1.Patient does not have L68Q mutation
•2.Patient has clinically significant illness, mental or physical, that, in the opinion of the investigator, might confound the results of the study, pose additional risk to the patient by their participation, or prevent/impede the patient from completing the study.
•3.Patient is pregnant or attempting to become pregnant
•4.Patient tests positive for illicit drugs (including marijuana) or has history of drug abuse within the last 2 years.
•5.Patient consumes excessive amounts of alcoholic beverages.
•6.There is any concern by the investigator regarding the patient’s safety, compliance, or suitability with respect to his/her participation in the study.

发起方

Arctic Therapeutics ehf