NCT03305016已完成3 期
fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD
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
- 146
- 试验地点
- 38
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (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, Canada, Australia, and New Zealand.
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy.
- •6 months to 17 years old, inclusive, at Visit 1
- •If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1
- •If ≥ 6 months but < 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1
- •Tanner stage < 5 at Visit 1
- •Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males)
- •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
- •Weight of < 5.5 kg or > 80 kg at Visit 1
- •Females of child-bearing potential
- •History of malignant disease
- •Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism)
- •Poorly-controlled diabetes mellitus (HbA1c >8.0%) or diabetic complications
- •Known neutralizing antibodies against hGH
- •Major medical conditions, unless approved by Medical Monitor
- •Presence of contraindications to hGH treatment
- •Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
- •Participation in any other trial of an investigational agent within 30 days prior to Visit 1
- •Prior exposure to investigational hGH
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 Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 26 weeks
Safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
次要结局
- Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation(26 weeks)
- Annualized Height Velocity (AHV) at 26 Weeks of Weekly Lonapegsomatropin Treatment(26 weeks)
- Number of Subjects With IGF-1 Standard Deviation Score (SDS) in the Range of 0.0 to +2.0 at 26 Weeks of Weekly Lonapegsomatropin Treatment(26 weeks)
- Change in Height Standard Deviation Scores (SDS) at 26 Weeks of Weekly Lonapegsomatropin Treatment(Baseline and 26 weeks)
研究者
研究点 (38)
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