NCT01571596已完成1 期
An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Safety and Efficacy of Repeated SC Injections of KRN23.
研究概览
简要总结
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
- •eGFR ≥ 60 mL/min
- •Corrected Ca < 10.8 mg/dL
- •For female of child-bearing potential, a negative serum pregnancy test
- •A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
- •Additional inclusion criteria apply
排除标准
- •Subject experienced a safety-related event in the KRN23-INT-001 study
- •Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
- •Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
- •Condition which could present a concern for either the subject's safety or difficulty with data interpretation
- •Additional exclusion criteria apply
研究组 & 干预措施
KRN23
Experimental
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
干预措施: KRN23 (Drug)
结局指标
主要结局
Safety and Efficacy of Repeated SC Injections of KRN23.
时间窗: 13.5 months,(50 visits)
Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
次要结局
- Evaluation of Effect of Repeated SC Injections of KRN23(13.5 months, (50 visits))
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-InhibitorAngioedemaNCT04444895Shire73
已完成
1 期
A Repeated Study of KRN23 in Adults With X-Linked HypophosphatemiaX-linked HypophosphatemiaNCT01340482Kyowa Kirin Co., Ltd.29
已完成
1 期
Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT01385657Regeneron Pharmaceuticals37
已完成
2 期
Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisNCT02379052Regeneron Pharmaceuticals47
已完成
1 期
A Study of Japanese Rheumatoid Arthritis ParticipantsRheumatoid ArthritisNCT01253291Eli Lilly and Company26