NCT03435627已完成不适用
Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of adverse drug reactions (ADR)
研究概览
简要总结
The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as agreed with the study doctor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
- •For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-
- •For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
- •Male or female, 3 years old or over, bone age: less than 17 years old for male / less than 15 years old for female.
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Known or suspected allergy to study products or related products.
- •In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.
研究组 & 干预措施
Norditropin® (naïve participants)
The treatment period of Norditropin® for naïve participants will be up to 208 weeks.
干预措施: Somatropin (Drug)
Norditropin® (non-naïve participants)
The treatment period of Norditropin® for non-naïve participants will be up to 442 weeks.
干预措施: Somatropin (Drug)
结局指标
主要结局
Number of adverse drug reactions (ADR)
时间窗: Weeks 0-208
Count of events
次要结局
- Change in insulin like growth factor I standard deviation score (IGF-I SDS) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in high-density lipoprotein cholesterol (HDL-C) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in Low-density lipoprotein cholesterol (LDL-C) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in total cholesterol (T-CHO) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Number of serious adverse event (SAE)(Week 0-208)
- Number of cardiac adverse event (AE)(Week 0-208)
- Change in insulin like growth factor I (IGF-I) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in insulin like growth factor I standard deviation score (IGF-I SDS) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in aspartate aminotransferase (AST) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in alanine aminotransferase (ALT) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in high-density lipoprotein cholesterol (HDL-C) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in platelet (PLT) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in bone age (BA) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in bone age (BA) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in bone age/chronological age (BA/CA) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in electrocardiogram (ECG) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in electrocardiogram (ECG) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in height standard deviation score (HSDS) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in insulin like growth factor I (IGF-I) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Number of serious adverse drug reaction (SADR)(Week 0-208)
- Change in aspartate aminotransferase (AST) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Height velocity standard deviation score (HVSDS) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in haemoglobin A1c (HbA1c) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in total cholesterol (T-CHO) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in triglyceride (TG) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in triglyceride (TG) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in free triiodothyronine (FT-3) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in free thyroxine (FT-4) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in white blood cell (WBC) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in platelet (PLT) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in bone age/chronological age (BA/CA) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in haemoglobin A1c (HbA1c) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in alanine aminotransferase (ALT) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in Low-density lipoprotein cholesterol (LDL-C) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in thyroid stimulation hormone(TSH) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Change in white blood cell (WBC) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in free thyroxine (FT-4) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in thyroid stimulation hormone(TSH) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in free triiodothyronine (FT-3) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Change in height standard deviation score (HSDS) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Height velocity (HV) for non-naïve patients(Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks)
- Height velocity (HV) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
- Height velocity standard deviation score (HVSDS) for naïve patients(Weeks 0, 52, 104, 156, and 208 weeks)
研究者
研究点 (1)
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