A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults with Hypoparathyroidism - A Clinical Extension Study - Not applicable

PS Pharmaceuticals, Inc.0 个研究点目标入组 30 人开始时间: 2011年5月23日最近更新: 2012年11月12日

适应症

试验速览

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•Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR
•Enrolled in REPLACE and dropped out during screening, but currently meet inclusion/exclusion criteria for REPLACE
•Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh
•No evidence of any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558
•No evidence of any disease or condition, in the opinion of the investigator, which has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study:
•1. Any condition that, in the investigator's opinion after consultation with the sponsor would preclude the safe use of NPSP558
•2. Any disease or condition in the opinion of the investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements
•3. Pregnant or lactating women

发起方

PS Pharmaceuticals, Inc.