Phase II Study of Growth Hormone in Children With Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 9
研究概览
简要总结
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.
II. Determine the effect of growth hormone on pulmonary function in these patients.
III. Determine the impact of this drug on the quality of life in these patients.
IV. Determine if the clinical response from this drug is sustained in these patients.
详细描述
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.
Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.
Quality of life is assessed at baseline and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of prepubertal cystic fibrosis
- •No colonization by Burkholderia cepacia
- •-Prior/Concurrent Therapy--
- •No prior or concurrent insulin requirement
- •-Patient Characteristics--
- •Hematopoietic: No hematologic disease
- •Hepatic: No liver disease
- •Renal: No kidney disease
- •Pulmonary: Must be able to perform pulmonary function testing
- •Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex
排除标准
- 未提供