NCT01460030已完成3 期
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Corrected serum calcium
研究概览
简要总结
This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium > 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is > 12.5 mg/dL at the screening test).
- •Patients who provided their voluntary written informed consent to participate in the study.
排除标准
- •Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment.
- •Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma.
- •Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
- •Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.
研究组 & 干预措施
KRN1493
Experimental
干预措施: Cinacalcet HCl (Drug)
结局指标
主要结局
Corrected serum calcium
次要结局
- Serum intact parathyroid hormone
研究者
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