NCT03280264已完成3 期
An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
研究概览
简要总结
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Personally submitted written voluntary informed consent to participate in the study
- •Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
- •Corrected serum calcium level is > 11.3 mg/dL at screening.
排除标准
- •Patients receiving cinacalcet hydrochloride within 2 weeks before screening
- •Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
- •Severe heart disease
- •Severe hepatic dysfunction
- •Uncontrolled hypertension and/or diabetes
- •Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
研究组 & 干预措施
KHK7580
Experimental
oral administration
干预措施: KHK7580 (Drug)
结局指标
主要结局
The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
时间窗: Up to 24 weeks
次要结局
- Serum Corrected Ca Level(up to 52 weeks)
- Serum Intact Parathyroid Hormone Level(up to 52 weeks)
- Serum Whole Parathyroid Hormone Level(up to 52 weeks)
- The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.(up to 24 weeks)
研究者
研究点 (1)
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