MK-0677 IN GROWTH HORMONE DEFICIENT CHILDREN

目前，重组人生长激素是GH缺乏症儿童唯一可用的治疗方法。 这种疗法导致在治疗的第一年内生长速度急剧加快，然后在随后的几年治疗中通常缓慢下降。 用rhGH治疗是胃肠外的且昂贵的，并且不模仿GH释放的正常脉动模式。 MK-0677是生长激素释放肽的口服活性模拟物，可刺激GH的脉冲式分泌。 本研究旨在为后续试验提供剂量范围确定信息，并评估MK-0677用于既往接受重组GH治疗的生长激素缺乏儿童的安全性和疗效。 假设治疗将导致治疗6个月后平均生长速度的剂量依赖性差异，MK-0677将是安全的且耐受性良好。 目的是评估疗效和安全性，并获得与重组GH治疗的比较数据。 迄今为止，已招募了4名受试者。

Currently, recombinant human growth hormone constitutes the only therapy available to children with GH deficiency. This therapy results in a dramatic acceleratin of growth velocity during the first year of therapy then generally slowly declines over subsequent years of treatment. Therapy with rhGH is parenteral and expensive and does not mimic the normal pulsatile pattern of GH release. MK-0677 is an orally active mimetic of the growth hormone-releasing peptides which stimulates pulsatile secretion of GH. This study is intended to provide dose-ranging information for subsequent trials and to assess the safety and efficacy of administering MK-0677 to growth hormone deficient children who have been previously treated with recombinant GH. The hyptheses are that treatment will result in dose-dependent differences in mean growth velocity after 6 months of treatment and MK-0677 will be safe and well tolerated. The objectives are to assess the efficacy and safety and to obtain comparative data to treatment with recombinant GH. Four subjects have been enrolled to date.