NCT00537914已完成4 期
Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
研究概览
简要总结
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
详细描述
Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
- •Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
- •Birth weight and/or length below -2 standard deviations (SD) for gestational age
排除标准
- •Onset of puberty
- •Closed epiphyses
- •Diabetes mellitus type I or type II
- •Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
- •Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
- •Known IGF-I level above +2SD for sex and age
- •Acute critical illness
- •Previous treatment with any hGH preparation
- •Treatment with antidiabetic medication (e.g. metformin, insulin)
- •Drug abuse, substance abuse, or alcohol abuse
研究组 & 干预措施
Omnitrope
Experimental
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
干预措施: Omnitrope (Drug)
结局指标
主要结局
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
时间窗: throughout the study, approximately 13 years
The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.
次要结局
- Mean Change in Height (H) (cm) From Baseline(Baseline, 3 months, 1 year, 2 years, 5 years and 9 years)
- Mean Change in Height Standard Deviation Score Over Time From Baseline(Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years)
- Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline(Baseline, 3 months, 1 year, 2 years, 5 years and 9 years)
- Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline(Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years)
- Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline(Baseline, 3 months, 1 year, 2 years, 5 years and 9 years)
- Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline(Baseline, 3 months, 1 year, 2 years, 5 years and 9 years)
- Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment(throughout the study, approximately 13 years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Estudio de seguridad a largo plazo en los pacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad--------------------------------------------------------Long-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at one year of age - CLARINET LONG TERMpacientes incluidos en el estudio CLARINET con cardiopatía congénita cianosante paliada con derivación sistémica a la arteria pulmonar en los cuales persista la derivación al año de edad------------------------------------------------------Patients at one year of age who are included in CLARINET, with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt, and for whom the shunt is still in place.MedDRA version: 8.1Level: LLTClassification code 10019273Term: Heart disease congenitalEUCTR2008-004999-53-ESsanofi-aventis recherche & développement49
已完成
2 期
Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa SimplexEpidermolysis BullosaEpidermolysis Bullosa SimplexNCT03389308Castle Creek Pharmaceuticals, LLC51
已完成
2 期
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)Alagille SyndromeNCT02047318Mirum Pharmaceuticals, Inc.19
已完成
2 期
Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent PatientsHemochromatosisNCT00349453Lipomed24
已完成
3 期
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831Schizophreniform DisorderSchizophreniaBipolar I DisorderNCT03201757Alkermes, Inc.524