NCT01746862已完成3 期
A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature
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
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method
研究概览
简要总结
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS. The subjects will be treated with 0.067 milligram/kilogram/day (mg/kg/day) of Saizen®, weight base dose, for 12 months (12 months of treatment in the test group, and 6 months of no treatment and then 6 months of treatment in the control group).
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 5 years
- •Pre-pubertal; testicular volume less than 4 milliliter (in males) and breast Stage 1 (in females)
- •The official records of height (for example records measured in hospitals or schools) during previous 6 months or more preceding inclusion in the study (self-measurement of the height at home will not be considered as a valid record)
- •Height less than or equal to 3rd percentile compared to same sex, same age
- •Peak serum growth hormone (GH) greater than 10 microgram per liter (mcg/L) in GH stimulation test (results of peak serum GH greater than 10 mcg/L in GH stimulation test within 1 year can be used instead)
- •Naive to GH therapy
- •Normal birth weight (that is greater than or equal to 3rd percentile when compared to same sex)
- •Normal thyroid function
- •Normal karyotype in girls
- •Written informed consent from parent/guardian
- •Written informed consent from the subject who speaks, understand, read, and write Korean
- •Bone age less than 10 years in boys and less than 9 years in girls, whose difference between the bone and chronological age is no more than 3 years
排除标准
- •Puberty development (Tanner stage greater than or equal to 2)
- •Skeletal dysplasia or abnormal body proportions
- •Chronic systemic illness
- •Dysmorphic syndrome
- •Growth Hormone Deficiency
- •Small for Gestational Age (SGA)
- •Current medication for Attention deficit hyperactivity disorder (ADHD) or hyperactivity disorder
- •Current medication with drugs that may influence secretion or action of growth hormone (such as estrogen, androgen, anabolic steroid, corticosteroid, thyroxine, aromatase inhibitors)
- •Diabetes mellitus
- •Kidney transplantation
- •Acute critical illness, including complications following open heart surgery, abdominal surgery or multiple accidental trauma
- •Acute respiratory failure
- •Malignancy or previous therapy for malignancy
- •Known hypersensitivity to somatotropin or any of its excipients including cresol or glycerol
- •Closed epiphyses, progression or recurrence of an underlying intracranial tumor, chronic renal disease
- •Endocrinologic or metabolic disorders such as Prader-Willi syndrome; Russel-Silver syndrome; Seckel syndrome; Down syndrome; Cushing syndrome; Noonan syndrome; short stature caused by other chromosomal abnormalities
- •The disorders that explain short stature such as psychiatric disorders, nutritional disorders, and chronic debilitating diseases
- •Participation in another clinical trial within the past 3 months
- •Status of legal incapacity or limited legal capacity of the parents or legal guardian
研究组 & 干预措施
Saizen Test Group
Experimental
干预措施: Saizen® (Drug)
Saizen Control Group
Active Comparator
干预措施: Saizen® (Drug)
结局指标
主要结局
Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method
时间窗: Baseline, Month 6
Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = (\[Baseline height minus height measurement obtained at least 6 months prior\] / 6) \* 12. Height velocity at Month 6 = (\[Month 6 height minus height measurement obtained at least 6 months prior\] / 6) \* 12.
次要结局
- Change From Baseline in Height Velocity at Month 12(Baseline, Month 12)
- Change From Baseline in Height at Month 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12(Baseline, Month 6, Month 12)
- Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12(Baseline, Month 6, Month 12)
- Percentage of Adherence to Study Treatment(6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group))
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs(Baseline up to Month 13)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery SystemHealthy Male SubjectsNCT05275010Hoffmann-La Roche151
进行中（未招募）
1 期
Efficacy and safety of LNP023 compared with rituximab in subjects with idiopathic membranous nephropathy.Idiopathic Membranous nephropathyMedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857EUCTR2019-001734-34-NLovartis Pharma AG52
已完成
不适用
A RANDOMIZED, OPEN-LABEL, 2-ARM PARALLEL-GROUP, MULTICENTER, 26-WEEK STUDY ASSESSING THE SAFETY AND EFFICACY OF HOE901-U300 VERSUS LANTUS IN OLDER PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON ANTIDIABETIC REGIMENS.PER-078-14Sanofi Aventis Recherche & Development,71
已完成
Unknown
A Phase 1 Study to Compare the Pharmacokinetics and Safety of CT-P13 (CT-P13 SC) Auto-injector and Pre-filled Syringe for Subcutaneous Administration in Healthy Adult SubjectsKCT0009574Celltrion148
进行中（未招募）
1 期
A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients with Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or with Basal Insulin as Their Only Insulin - SENIOREUCTR2014-002399-10-ITSanofi-aventis recherche & développement1,014