NCT02092077终止2 期
A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
Teva Pharmaceutical Industries, Ltd.34 个研究点 分布在 13 个国家目标入组 65 人开始时间: 2014年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 34
- 主要终点
- Height velocity (HV)
研究概览
简要总结
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TV-1106 0.554 mg
Experimental
干预措施: TV-1106 (Drug)
TV-1106 0.924 mg/kg
Experimental
干预措施: TV-1106 (Drug)
TV-1106 1.20 mg/kg
Experimental
干预措施: TV-1106 (Drug)
somatropin 0.033 mg/kg/day
Active Comparator
Dosages may be adjusted according to findings and as necessary
干预措施: somatropin (Drug)
结局指标
主要结局
Height velocity (HV)
时间窗: Month 6
次要结局
- Height velocity standard deviation score (HV-SDS)(Months 6 and 12)
- Height velocity (HV)(Month 12)
- Number of participants with adverse events(up to 24 months)
- Height standard deviation score (H-SDS)(Months 6 and 12)
研究者
研究点 (34)
Loading locations...
相似试验
招募中
1 期
Anti-GD2 ADC M3554 in Advanced Solid TumorsAdvanced Solid TumorNCT06641908EMD Serono Research & Development Institute, Inc.52
终止
1 期
A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)Relapsed/Refractory Peripheral T-cell LymphomaNCT05403450Taiho Oncology, Inc.33
已完成
1 期
Phase I Trial of BAY1251152 for Advanced Blood CancersHematologic NeoplasmsNCT02745743Bayer21
招募中
1 期
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)Necrotizing EnterocolitisNCT06315738Noveome Biotherapeutics, formerly Stemnion36
进行中（未招募）
1 期
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid TumoursHead and Neck Squamous Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid TumorMelanomaColorectal CancerNCT06305247Ipsen36