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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
研究概览
简要总结
This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.
详细描述
Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all the following inclusion criteria can be enrolled into this study:
- •Signed and dated informed consent form (ICF) before any study-related procedures are performed
- •Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR Enrolled in REPLACE and dropped out during optimization, 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
- •Willingness and ability to understand and comply with the protocol
- •Women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate serum follicle stimulating hormone (FSH) levels (> 40 IU/L); (2) surgically sterilized; OR (3) of childbearing potential with a negative pregnancy test at screening and who consent to use two acceptable methods of contraception for the duration of the study, with pregnancy testing at every scheduled visit during the treatment period . Female partners (who are of childbearing potential) of male study patients must also use acceptable forms of contraception during their partner's participation
排除标准
- •Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study:
- •Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558
- •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
- •Pregnant or lactating woman
研究组 & 干预措施
NPSP558
干预措施: NPSP558 (Drug)
结局指标
主要结局
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
时间窗: 24 Weeks
A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
次要结局
- Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit(24 Weeks)
- Mean Percentage Changes From Baseline in Oral Calcium at Each Visit(24 Weeks)
- Proportion of Patients Achieving the Primary Endpoint at Each Visit(24 Weeks)
- Mean Change From Baseline in 24-hour Urine Calcium Excretion(24 Weeks)