EUCTR2008-008240-25-SI进行中（未招募）不适用
A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient children
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the GHD child.)
- •2. Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level < 7 ng/mL. For children with three or more pituitary hormone deficiency only one GH provocation test will be needed. If in accordance with country specific practice growth hormone insufficiency can be defined by only one GH provocation test, defined as a peak of GH level < 7 ng/mL.
- •3. Pre-pubertal children.
- •4. Boys: Age = 6 year and = 12 years.
- •Girls: Age = 6 year and = 12 years.
- •5. Body weight = 16 kg.
- •6. GH replacement treatment = 3 month.
- •All GHD children will be required to discontinue GH replacement treatment 7 days (+2days) prior to NNC126-0083 and Norditropin NordiFlex® administration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known or suspected allergy to trial product(s) or related products.
- •2. Previous participation (randomisation) in this trial.
- •3. Participation in any other clinical trial involving any investigational products within the last three months prior
- •to this trial.
- •4. Evidence of tumour growth or malignant disease.
- •5. GHD children with overt diabetes mellitus (fasting blood glucose > 7 mmol/l (126 mg/dL)).
- •6. GHD children with a history of previous hypoglycaemic episode(s) after cessation of GH treatment.
- •7. Known chromosomal abnormalities and medical syndromes” (Turner syndrome, Laron syndrome, Noonan
- •syndrome or absence of growth hormone receptors).
- •8. Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome, skeletal dysplasias.
- •9. Poorly controlled or uncontrolled pituitary insufficiencies of other axes (e.g., thyroid-stimulating hormone,
- •adrenocorticotropic hormone/cortisol, vasopressin deficiency): Children who are on stable replacement therapy
- •for less than 3 months for other hormonal deficiencies prior to enrolment.
- •10. Major medical conditions and/or presence of contraindication to GH treatment.
- •11. History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the
- •trial or pose additional risk in administering the trial product to the GHD child
- •12. Clinically significant illness within 4 weeks of dosing.
- •13. Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the
- •Investigator.
- •14. Active hepatitis B, measured by surface antigen B (HbsAg) and/or active hepatitis C, measured by positive
- •hepatitis C virus antibody test.
- •15. Clinically significant abnormal ECG at screening as evaluated by Investigator.
- •16. Surgery or trauma with significant blood loss within the last 3 months prior to dosing.
- •17. Mental incapacity of the child, parents/legal guardian or language barriers which preclude adequate
- •understanding or cooperation, who are unwilling to participate in the trial or who in the opinion of their general
- •practitioner or the Investigator should not participate in the trial.
- •18. The GHD child and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
- •19. Any condition interfering with trial participation or evaluation or that may be hazardous to the GHD child.
研究者
相似试验
进行中（未招募）
1 期
A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childreEUCTR2008-008240-25-FRovo Nordisk A/S
进行中（未招募）
不适用
A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex® in growth hormone deficient childreEUCTR2008-008240-25-GBovo Nordisk A/S32
进行中（未招募）
不适用
A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childregrowth hormone deficiency (GHD) in childrenMedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiencyEUCTR2008-008240-25-DKovo Nordisk A/S32
进行中（未招募）
不适用
A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) compared to Norditropin NordiFlex? in growth hormone deficient childregrowth hormone deficiency (GHD) in childrenMedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiencyEUCTR2008-008240-25-BEovo Nordisk A/S32
尚未招募
不适用
Evaluating Dose-proportionality of Dilatrend Suspended-Release Capsule in healthy male volunteersDiseases of the circulatory systemKCT0000133Chong Kun Dang30