An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.
详细描述
This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed the Week 12 Visit in MBX-2H1002 Study.
- •Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
- •Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
- •Screening visit:
- •Postsurgical chronic hypoparathyroidism
- •Idiopathic hypoparathyroidism
- •Autoimmune hypoparathyroidism
- •Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
- •In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
排除标准
- 未提供
研究组 & 干预措施
400 µg once-weekly by subcutaneous injection
干预措施: 400 µg of MBX 2109 once-weekly by subcutaneous injection (Drug)
200-1600 µg once-weekly by subcutaneous injection
干预措施: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection (Drug)
结局指标
主要结局
To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
时间窗: 104 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
次要结局
未报告次要终点