NCT03972345Enrolling By Invitation不适用
A Non-interventional, Prospective Study in Germany to Investigate the Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in a Patient Population With Isolated Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Near final height (NFH) standard deviation score (SDS) measured in scores
研究概览
简要总结
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and teenagers in daily practice in Germany. This study will look mainly at the difference in near final height between children and teenagers who adhere to their therapy plan with Norditropin® to non-adherent patients. Participants will get Norditropin® as prescribed to them by their doctor. The study will last as long as the therapy with growth hormone is seen necessary by the participants' doctors and the participants, up to a maximum of 10 years. During the visits at the participants' doctors participants will be asked to fill in a questionnaire.
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
- 0 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any study-related activities.
- •The parent or legally acceptable representative of the child must sign and date the Informed Consent Form (according to local requirements) and
- •The child must sign and date the Child Assent Form or provide oral assent (if required according to local requirements).
- •The decision to initiate treatment with commercially available Norditropin® FlexPro® has been made by the treating physician and the patient's parents/legal guardian before and independently of the decision to include the patient in this study.
- •Male or female, all age groups equal to or below 15 years with more than 2 years expected remaining treatment time until reaching NFH. Patients who self-inject should be above 8 years of age in order to be able to fill in the questionnaire.
- •Children being GH naïve at baseline with one of the following confirmed diagnoses
- •Isolated growth hormone deficiency (iGHD)
- •Small for gestational age (SGA)
排除标准
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Patients who have an expected future duration of therapy of less than 2 years are not eligible for the study.
研究组 & 干预措施
Paediatric patients with iGHD or SGA
Children with one of the following confirmed diagnoses: isolated growth hormone deficiency (iGHD) or small for gestational age (SGA)
干预措施: Norditropin® FlexPro® (Drug)
结局指标
主要结局
Near final height (NFH) standard deviation score (SDS) measured in scores
时间窗: At the end of the study (up to 10 years)
SDS, -3 to +3
次要结局
- Change in growth rate (height velocity standard deviation score, HV SDS)(From baseline (month 0) to end of study (up to 10 years))
- Change in growth rate (HV SDS) between visits (usually patients are seen every 3 to 6 months)(From baseline (month 0) to end of study (up to 10 years))
- Adherence measured as number of medication devices returned versus number of prescribed devices for the period between visits(From baseline (month 0) to end of study (up to 10 years))
- Change of self-rated adherence level throughout the study measured in newly developed PRO questionnaire each time questionnaire is filled out (preferably at each visit)(From baseline (month 0) to end of study (up to 10 years))
- Adherence response as indicated in question at the bottom of newly developed Patient Reported Outcome (PRO) questionnaire each time questionnaire is filled out (preferably at each visit)(From baseline (month 0) to end of study (up to 10 years))
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Prospective voluntary clinical research that supports carbohydrate restriction and aerobic exercise and supports physical condition improvement for untreated patients who are pointed out hyperuricemia by medical checkups.HyperuricemiaJPRN-UMIN000037135Sendai Tokushukai Hospital500
招募中
不适用
A clinical trial to study the efficacy of daily versus twice weekly therapy with oral calcitriol for controlling secondary hyperparathyroidsim in pre-dialysis CKD patients.CTRI/2011/12/002263AIIMS50
进行中（未招募）
4 期
Study to evaluate the efficacy and safety of salmon protein hydrolyate in whey protein isolate powder to improve hemoglobin and serum ferritin in anaemic patientsCTRI/2014/02/004433Hofseth Biocare AS48
已完成
不适用
A prospective, non-interventional study to investigate the effectiveness of a recombinant fusion protein linking coagulation Factor IX with recombinant albumin (rIX-FP) in patients with hemophilia BD67Hereditary factor IX deficiencyDRKS00015079CSL Behring GmbH73
尚未招募
不适用
A non-interventional, prospective study to evaluate change in physical activity, relationship satisfaction and psychological well-being in patients with rheumatoid arthritis after introduction of the JAK inhibitor filgotinib and also in their partners.M06.8Other specified rheumatoid arthritisDRKS00032128Helios Fachklinik Vogelsang-Gommern, Rheumatologie40