Multicenter Open-label, Randomized, Dose-finding, Parallel-group, Safety and Efficacy Trial of Subcutaneous Administration of Serostim® (Mammalian Cell-derived Recombinant Human Growth Hormone, r-hGH) in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 142
- 主要终点
- Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36
研究概览
简要总结
This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete all treatments prescribed by the antecedent protocol (Study 22388)
- •Be able and willing to comply with the protocol for the duration of the study, including concomitant therapy restrictions
- •Have given written informed consent
- •If female, be post-menopausal, surgically sterile, or using adequate contraception
排除标准
- •Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (Study 22388)
- •Withdrew from the antecedent study or was discontinued prematurely for any other reason
- •Based on the Final Visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the Final Visit
- •Based on the Final Visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the Final Visit. This does not apply to subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screening), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screening)
研究组 & 干预措施
Serostim® (1 mg)
干预措施: Serostim® (Drug)
Serostim® (2 mg)
干预措施: Serostim® (Drug)
Serostim® (4 mg)
干预措施: Serostim® (Drug)
结局指标
主要结局
Percent change from Week 12 in trunk fat quantified by Dual-energy X-ray absorptiometry (DXA) at Week 36
时间窗: Week 12 and Week 36
次要结局
- Change from Week 12 in Dorsocervical Fat Pad at Week 36(Week 12 and Week 36)
- Change from Week 12 in total body fat quantified by DXA at Week 36(Week 12 and Week 36)
- Change from Week 12 in lean body mass quantified by DXA at Week 36(Week 12 and Week 36)
- Change from Week 12 in maximal chest, waist, and hip circumference at Week 36(Week 12 and Week 36)
- Change from Week 12 in waist/hip ratio at Week 36(Week 12 and Week 36)
- Change from Week 12 in ratio of trunk fat to limb fat quantified by DXA at Week 36(Week 12 and Week 36)
- Change from Week 12 in weight measured on a calibrated scale at Week 36(Week 12 and Week 36)