JPRN-jRCT2080223716已完成3 期
Phase 3, Open-label Study of ITM-014 in patients with thyroid-stimulating hormone-secreting pituitary adenoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
The thyroid function and tumor size were favorably controlled and clinical symptoms was improved after the start of administration of ITM-014. No new concern on the safety was found.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria
- •1. Patients who are diagnosed as TSH-secreting pituitary adenoma
- •2. Patients who are difficult to perform a surgery for TSH-secreting pituitary adenoma (including patients who are diagnosed necessary by preoperative treatment), patients who do not wish to have a surgery, or patients with postoperative residual tumor
排除标准
- •Main Exclusion Criteria
- •1. Patients with hypersensitivity to somatostatin analogs
- •2. Patients with symptomatic cholelithiasis
- •3. Patients who have a malignant tumor
- •4. Patients with liver dysfunction or renal dysfunction
- •5. Patients who have a known or a history of alcoholism or drug addiction
- •6. Women who are pregnant or breastfeeding, or suspected of being pregnant
研究者
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