An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years

ANTHERA Pharmaceuticals, Inc.0 个研究点目标入组 70 人开始时间: 2016年8月2日最近更新: 2018年4月30日

适应症

试验速览

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•Subjects are eligible for enrollment if they meet the following inclusion criteria:
•1. Male or female subjects who received liprotamase and completed Study AN-EPI3331.
•2. Signed informed consent by subject and/or subject’s legally authorized representative.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 35
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Any medical, psychological, or social condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study or confound interpretation of study results.
•2.Treatment with any PERT other than study drug, investigational drugs, or devices
•3.Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study, or who have a positive pregnancy test at Visit Day 1. All sexually-active subjects of reproductive potential are required to remain on a reliable method of birth control. Females and males are required to continue using a reliable method of birth control throughout the study, and for at least 3 months following completion of study therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy.

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