Parathyroid Allotransplant for Treatment of Hypoparathyroidism: PATTH
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Levels of intact PTH
研究概览
简要总结
This study is being done to see if transplanting parathyroid tissue into the forearm will help hypo-parathyroid patients achieve parathyroid hormone (PTH) levels that would help normalize their serum calcium and phosphorus levels. The parathyroid tissue used in this study will come from cadaveric tissues that were donated at the time of the death of the donor(s).
详细描述
The company that makes the parathyroid hormone NATPARA will no longer be making the product by the end of 2024 which is one of the reasons the investigators are doing this study: to see if parathyroid transplantation is another way to treat hypoparathyroidism. This procedure is investigational and one of the first times the procedure is being done in humans. It is not approved by the FDA.
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 —（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
Parathyroid Allotransplant
Parathyroid Allotransplant to treat hypoparathyroidism
干预措施: Parathyroid Allotransplant (Biological)
结局指标
主要结局
Levels of intact PTH
时间窗: From baseline to week 52 (year 1)
The primary efficacy endpoint is attainment of levels of intact PTH that are in the normal target range and at least a doubling of the baseline intact PTH level prior to transplantation
Incidence of Adverse Events
时间窗: From baseline to Year 1
The primary safety endpoint is the incidence of adverse events related to the transplant procedure or immunosuppression, incidence of post- transplant infections and malignancies, incidence of de novo sensitization
次要结局
- Dose of oral calcium supplements and calcitrol(From baseline to week 52 (year 1))
- Dose of subcutaneous parathyroid hormone (PTH) replacement therapy(From baseline to week 52 (year 1))
- PTH replacement therapy(From baseline to week 52 (year 1))
研究者
Peter Stock
Professor of Surgery (MD, PhD)
University of California, San Francisco