NCT01822340已完成2 期
A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change of IGF-I levels in function of time, and dose strengths
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.
详细描述
- To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment
- To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
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
- 23 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
- •r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
- •Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m
- •Female patients must have a negative serum pregnancy test at inclusion.
- •Confirmed to be negative for anti r-hGH antibodies at the time of screening.
- •Willing and able to provide written informed consent prior to performing any study procedures.
排除标准
- •Patients with childhood onset of GHD treated with r-hGH before the age of
- •Current antitumor therapy.
- •Subjects presenting with any clinically significant ECG abnormality.
- •Evidence of intracranial hypertension.
- •Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal).
- •Pregnancy and breastfeeding;
研究组 & 干预措施
Cohort 1
Experimental
Once weekly HM10560A
干预措施: HM10560A (Drug)
Cohort 2
Experimental
Once weekly HM10560A
干预措施: HM10560A (Drug)
Cohort 3
Experimental
Once weekly HM10560A
干预措施: HM10560A (Drug)
Cohort 4
Experimental
Biweekly HM10560A
干预措施: HM10560A (Drug)
Cohort 5
Active Comparator
Once daily Genotropin
干预措施: Genotropin (Drug)
结局指标
主要结局
Change of IGF-I levels in function of time, and dose strengths
时间窗: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
The results from each month minus baseline
次要结局
- IGF-I SDS; changes to baseline in IGF-I SDS(baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months)
研究者
研究点 (1)
Loading locations...
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