NCT00566241终止1 期
An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Body weight and body composition
研究概览
简要总结
28 week pilot study to examine the efficacy of recombinant human IGF-1 on body weight and composition in adults with cystic fibrosis.
详细描述
28 week, double blind, cross over study to determine the efficacy of rhIGF-1 on body weight and body composition in patients with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of cystic fibrosis as proven by either sweat chloride or DNA analysis.
- •Age >= 18 yr.
- •Tanner stage: Femake Breasts: 4-5 Male Genitalia: 4-5
- •Exclusion criteria:
- •Hemoglobin A1C > 8.5 %
- •Diabetic retinopathy
- •Obstructive sleep apnea
- •Respiratory failure requiring mechanical ventilation.
- •Status post pulmonary transplantation.
- •Concurrent or recent (within past 6 months) receipt of human growth hormone.
- •History of adverse side effects to growth hormone other than carbohydrate intolerance.
- •Pregnancy or attempting pregnancy.
- •Women who are breast feeding.
- •Sexually active women who refuse to use or are incapable of responsibly using reliable contraception.
- •Proven non compliance with medical regimens.
- •Inability or refusal to take subcutaneous injections.
- •Known allergy to components in the IGF-I preparation.
排除标准
- 未提供
研究组 & 干预措施
IGF-1
Experimental
Recombinant human IGF-1
干预措施: recombinant human IGF-1 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Body weight and body composition
时间窗: 28 weeks
次要结局
- Pulmonary function(28 weeks)
- Carbohydrate tolerance(28 weeks)
研究者
Thomas A. Wilson
Professor of Pediatrics
Stony Brook University
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effects of Sandostatin LAR® in AcromegalyAcromegalyNCT01424241Columbia University21
招募中
不适用
Efficacy of Insulin Like Growth Factor-1(IGF-1) on Bone Regeneration in Intrabony Defects : A Clinico-radiograph StudyIntrabony Periodontal DefectNCT06426524Dr R Viswa Chandra24
暂停
2 期
Treatment of the lOw IGF-1 Syndrome aSsociated With Chronic Heart fAilure: A Randomized, Placebo-Controlled, Double-Blind Study.Chronic Heart FailureNCT01235273Federico II University100
已完成
不适用
Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's SyndromeWerner's SyndromeNCT00004815National Center for Research Resources (NCRR)1
已完成
2 期
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)22q13 Deletion SyndromePhelan-McDermid SyndromeNCT01525901Icahn School of Medicine at Mount Sinai19