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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2008-008240-25-FR |
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Date of registration:
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10/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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02/09/2009 |
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Target sample size:
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6 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008240-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: open-labelled, single dose, dose-escalation, sequential dose group trial
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Denmark
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France
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Slovenia
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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.
3. Pre-pubertal children.
4. Boys: Age = 9 year and = 12 years.
Girls: Age = 9 year and = 12 years.
5. Body weight = 25 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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growth hormone deficiency (GHD) in children
MedDRA version: 9.1
Level: LLT
Classification code 10056438
Term: Growth hormone deficiency
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Intervention(s)
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Product Code: NNC 126-0083
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: NNC 126-0083
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.8-
Trade Name: Norditropin NordiFlex® 10 mg/1.5 ml
Product Name: Norditropin NordiFlex® 10mg/1.5 ml
Product Code: N/A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Somatropin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-
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Primary Outcome(s)
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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.
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
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Primary end point(s): • Adverse Events
• Clinical laboratory safety (haematology, biochemistry and urinalysis)
• Fasting glucose
• Fasting insulin
• Physical examination
• Vital signs
• Body weight
• ECG
• Local tolerability
• NNC126-0083 antibodies
• Human Growth hormone antibodies
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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
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Secondary ID(s)
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NN8630-1824
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 18/06/2009
Contact:
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