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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2023-11-20 |
PaTHway China 试验:评价每日一次皮下注射 TransCon PTH 用于治疗成人甲状旁腺功能减退症的安全性和有效性的随机、双盲、安慰剂对照、平行设计的多中心 III 期临床试验(包含开放性扩展阶段)
评估 TransCon PTH 治疗 26 周后,对控制血钙(sCa)正常且停用常规治疗的有效性。常规治疗指活性维生素 D(骨化三醇)或其类似物(阿法骨化醇),联合钙补充剂>600 mg/天。
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism
PaTHway TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism
During the first 26 weeks of the trial, participants will be randomly assigned to one of two groups: one group will receive TransCon PTH and one group will receive placebo. All subjects will start with a fixed dose of study drug and will be individually and progressively titrated to an optimal dose over a 10 week period, followed by an individualized dosing period up to 16 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, and Denmark.
100 项与 Ascendis Pharma Bone Diseases A/S 相关的临床结果
0 项与 Ascendis Pharma Bone Diseases A/S 相关的专利(医药)
100 项与 Ascendis Pharma Bone Diseases A/S 相关的药物交易
100 项与 Ascendis Pharma Bone Diseases A/S 相关的转化医学