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 childre

Conditions: growth hormone deficiency (GHD) in children
MedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

Registration Number: EUCTR2008-008240-25-BE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine safety and tolerability of single subcutaneous (sc) doses of pegylated long-acting human growth hormone (NNC126-0083) compared to 7 days treatment with sc doses of Norditropin NordiFlex® in growth hormone deficient (GHD) children;Secondary Objective: To determine pharmacokinetics (PK) and pharmacodynamics (PD) of single sc doses of NNC126-0083 compared to 7 days treatment with sc doses of Norditropin NordiFlex® in GHD children.<br>To compare local tolerability (i.e. injection site reactions) of single sc doses of NNC126-0083 compared to 7 days treatment with sc doses of Norditropin NordiFlex® in GHD children<br>;Primary end point(s): • Adverse Events<br>• Clinical laboratory safety (haematology, biochemistry and urinalysis)<br>• Fasting glucose<br>• Fasting insulin<br>• Physical examination<br>• Vital signs<br>• Body weight<br>• ECG<br>• Local tolerability <br>• NNC126-0083 antibodies<br>• Human Growth hormone antibodies<br>

Secondary Outcome Measures

Name	Time	Method

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