MK-0677 IN GROWTH HORMONE DEFICIENT CHILDREN

生长激素缺乏儿童中的 MK-0677

• 批准号: 6276567
• 负责人: LEONA CUTTLER
• 金额: $ 1.83万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276567
• 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.

目前，重组人生长激素是唯一的治疗方法 GH 缺乏症儿童可用。 这种疗法的结果是 治疗第一年生长速度急剧加快 然后通常会在随后几年的治疗中缓慢下降。 rhGH 治疗是肠外治疗，价格昂贵，并且不模仿 GH 释放的正常脉动模式。 MK-0677 是一种口服活性药物 模拟生长激素释放肽，刺激 GH 的脉动分泌。这项研究的目的是提供剂量- 为后续试验提供信息并评估安全性和 MK-0677 对生长激素缺乏儿童的疗效 之前接受过重组 GH 治疗的人。 假设是 治疗将导致平均生长出现剂量依赖性差异 治疗 6 个月后的速度和 MK-0677 将是安全且良好的 容忍的。 目的是评估有效性和安全性并 获得与重组 GH 治疗的比较数据。