MK-0677 IN GROWTH HORMONE DEFICIENT CHILDREN

生长激素缺乏儿童中的 MK-0677

• 批准号: 6115333
• 负责人: LEONA CUTTLER
• 金额: $ 1.92万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115333
• 关键词: child (0-11); clinical research; drug screening /evaluation; endocrine disorder chemotherapy; growth hormone releasing hormone; hormone therapy; human subject; human therapy evaluation; oral administration; pituitary dwarfism

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.

目前，重组人生长激素是生长激素缺乏症儿童唯一可用的治疗方法。这种疗法导致生长速度在治疗的第一年显著加速，然后在随后的治疗中通常缓慢下降。重组人生长激素的治疗是非肠道的，费用昂贵，不能模仿正常的生长激素释放的脉动模式。MK-0677是一种口服活性模拟生长激素释放肽，可刺激生长激素的搏动性分泌。这项研究旨在为后续试验提供剂量范围的信息，并评估对以前曾接受重组生长激素治疗的生长激素缺乏症儿童使用MK-0677的安全性和有效性。推测治疗6个月后，平均生长速度将出现剂量依赖性的差异，MK-0677将是安全和耐受性良好的。目的是评估重组生长激素的有效性和安全性，并获得与重组生长激素治疗的比较数据。到目前为止，已经有四个科目被录取。