NCT03344458已完成3 期
enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 43
- 主要终点
- Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]
研究概览
简要总结
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have completed a prior phase 3 TransCon hGH trial
- •Children who have not permanently discontinued study drug in the prior trial
- •Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC
排除标准
- •Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications
- •Evidence of closed epiphyses, defined as bone age > 14.0 years for females or > 16.0 years for males
- •Major medical conditions unless approved by Medical Expert
- •Known hypersensitivity to the components of the trial medication
- •Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
- •Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
研究组 & 干预措施
TransCon hGH
Experimental
Once weekly subcutaneous injection of TransCon hGH
干预措施: TransCon hGH (Drug)
结局指标
主要结局
Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]
时间窗: Up to Week 208
Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
次要结局
- IGF-1 SDS by Visit(Up to Week 208)
- Height SDS - Change From Baseline(Up to Week 208)
- Annualized Height Velocity by Visit(Up to Week 208)
研究者
研究点 (43)
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