JPRN-jRCT2080223136已完成2 期
A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients with Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome and a Post-marketing Study of KRN23 Switched from the Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •At the time of switching to the post-marketing study:
- •1)Voluntary written informed consent to participate in the post-marketing study (if aged < 20 years at the time of consent, written informed consent must be obtained from his or her legally acceptable representative as well)
- •2)Switching to the post-marketing study is necessary and appropriate for the subject from the viewpoint of efficacy and safety, as judged by the investigator or subinvestigator.
排除标准
- •1) Use of the following drugs within 14 days prior to screening: pharmacologic vitamin D metabolites or analogs, or drugs for treating TIO/ENS including oral phosphate, aluminum hydroxide antacids, acetazolamide, or thiazide diuretics
- •2) Medication to suppress parathyroid hormone (PTH) (e.g., cinacalcet hydrochloride) within 60 days prior to screening
- •3) Blood or blood product transfusion within 60 days prior to screening
- •4) Chemotherapy for TIO or other malignant tumors within 4 months prior to screening
- •5) History of being positive for human immunodeficiency virus antibody, hepatitis B antigen and/or hepatitis C virus antibody
- •6) Predisposition to infection, or history of recurrent infection or known immunodeficiency
- •7) Pregnant or breastfeeding at screening or intention to become pregnant during the study; for male subjects, the partner's intention to become pregnant during the study
- •8) Use of an investigational product or device within 4 months prior to screening, or planning to receive other investigational product before completing all assessments in this study
- •9) Use of therapeutic monoclonal antibodies including KRN23 within 90 days prior to screening
- •10) History of allergic or anaphylactic reactions to KRN23, any of the KRN23 ingredients, or any other monoclonal antibodies
- •11) Anyone otherwise considered unsuitable participation in the study by the investigator or subinvestigator
研究者
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