A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 124
- 试验地点
- 31
- 主要终点
- The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.
研究概览
简要总结
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
详细描述
Patients with a history of hypoparathyroidism will be randomized to receive placebo or study drug for 24 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically, calcium levels in the blood and urine). In addition, the patients' intake of Vitamin D and calcium will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Sterile water for injection
干预措施: Placebo (Drug)
50, 75, 100 mcg NPSP558
Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
干预措施: NPSP558 (Drug)
结局指标
主要结局
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.
时间窗: Week 24 of dosing
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.
次要结局
- Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.(24 Weeks)
- Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.(8 Weeks)
- Percentage Changes From Baseline in Daily Calcium Dose at Week 24.(24 Weeks)