NCT00570011已完成3 期
Efficacy of Two Different Dose Regimens of Somatropin in Growth Hormone Deficient Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated.
研究概览
简要总结
An international study in which patients with GHD were randomized to receive somatropin at a dose of either 3 microg/kg/day or 6 microg/kg/day for the first three months. The dose was then doubled (6 microg/kg/day, LD or 12 microg/kg/day, CD) for the next three-months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients may be included in the study only if they meet all of the following criteria:
- •Adult males and females with GHD, arising during adult life from pituitary ablation or failure, onset of GHD have taken place at least 1 year before entering the study, or,
- •Adult males and females with GHD either idiopathic or secondary to pituitary disease arising in childhood.
- •Demonstrated GHD as documented by a negative response to a standard GH stimulation test within the last 5 years previous year (see Section 3.4.3, part b). Maximal peak must be less than 3.0 ng/ml.
- •Receiving replacement for other deficient hormones for at least 3 months prior to the start of the study, where necessary.
- •Have given informed consent.
排除标准
- •Patients will be excluded from the study for any of the following reasons:
- •Patients with clinically significant pulmonary, cardiac, hepatic, renal or neuromuscular disease or with chromosomal or genetic malformation syndromes.
- •Patients who have any evidence of an active tumorous process. Intercranial lesions must be inactive and any antitumour therapy must be complete.
- •Pregnant women and lactating females or women who decide to become pregnant during the study and who are not taking adequate contraceptives.
- •Patients thought unlikely to comply with the protocol.
- •Patients taking an investigational drug in the previous month.
研究组 & 干预措施
1
Experimental
干预措施: Somatropin (Drug)
2
Experimental
干预措施: Somatropin (Drug)
结局指标
主要结局
Plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA) as a function of changes in insulin levels was investigated.
时间窗: 6 months
次要结局
- Serum concentrations of Leptin, Insulin, IGFBP1, IGFBP2, IGF2(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy SubjectsHealthy VolunteersGrowth Hormone DeficiencyNCT03905850Novo Nordisk A/S33
已完成
3 期
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone DeficiencyChildhood-onset Growth Hormone DeficiencyPituitary DwarfismNCT00109733EMD Serono31
已完成
3 期
A Study of Zomacton in Children With Growth Hormone DeficiencyGrowth Hormone DeficiencyNCT00884000Ferring Pharmaceuticals165
已完成
3 期
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.Growth Hormone Deficiency in ChildrenNCT04970654Novo Nordisk A/S110
已完成
3 期
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short StatureIdiopathic Short Stature (ISS)NCT00355030Eli Lilly and Company91