A study comparing the effect and safety of once-weekly dosing of Somapacitan with daily administered Norditropin® in children with growth hormone deficiency.
Résumé de l'étude
In this study, the investigational drug Somapacitan is compared to daily administered Norditropin to assess safety and efficacy in children with growth hormone deficiency. Somapacitan is a long-acting growth hormone that needs to be injected subcutaneously once a week, whereas Norditropin needs to be injected subcutaneously once a day. A total of 192 patients will be randomly assigned by a computer system in a 2:1 ratio to one of the two investigational products – Somapacitan (growth hormone once a week) or Norditropin® (growth hormone once a day). The study is not blinded, meaning both the patient and the staff at the investigational site will know which treatment the patient is receiving. In Switzerland, 8 patients are planned across 3 investigational sites. This is an international study that will be conducted at multiple investigational sites worldwide.
(BASEC)
Intervention étudiée
The total study duration for each patient is 4 years.
The study includes a screening phase of approximately one week, during which it is decided whether the patients are eligible for the study. Eligible patients then begin a 52-week phase, during which they are randomly assigned to the investigational drug Somapacitan or the standard therapy with Norditropin. In the following 3 years, all study patients will be treated with Somapacitan to collect more data on the treatment and its safety.
The study includes a total of 19 visits to the study site and 1 phone contact with the principal investigator over 4 years.
During the visits to the study site, various examinations (e.g., hand X-ray, height, weight, ECG) will be performed, as well as blood samples taken.
(BASEC)
Maladie en cours d'investigation
Growth hormone deficiency
(BASEC)
The main inclusion criteria are: 1. Prepubertal children: - Boys between 2 1/2 years and 11 years - Girls between 2 1/2 years and 10 years 2. Confirmed diagnosis of growth hormone deficiency established by two different growth hormone stimulation tests conducted within 12 months prior to study enrollment. 3. No prior treatment with growth hormones or an insulin-like growth factor-I (IGF-I). (BASEC)
Critères d'exclusion
The main exclusion criteria are: 1. Any known or suspected clinically significant anomaly that could affect growth. 2. Use of medications that may impact growth. 3. Diagnosis of attention deficit hyperactivity disorder (ADHD) (BASEC)
Lieu de l’étude
Bâle, Berne, Zurich
(BASEC)
Sponsor
Novo Nordisk Pharma AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Maddalena Ghielmetti
+41 44 914 11 11
mdlg@clutternovonordisk.comNovo Nordisk Pharma AG
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
07.05.2019
(BASEC)
Identifiant de l'essai ICTRP
EUCTR2018-000231-27 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
REAL 4 - A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency (BASEC)
Titre académique
A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin? in children with growth hormone deficiency - REAL4 (ICTRP)
Titre public
A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin? once a day (ICTRP)
Maladie en cours d'investigation
Growth hormone deficiency in children
MedDRA version: 20.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] (ICTRP)
Intervention étudiée
Product Name: somapacitan 5 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.3-
Product Name: somapacitan 10 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-
Product Name: somapacitan 15 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Other descriptive name: SOMATROPIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-
(ICTRP)
Type d'essai
Interventional clinical trial of medicinal product (ICTRP)
Plan de l'étude
Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2 (ICTRP)
Critères d'inclusion/exclusion
Gender:
Female: yes
Male: yes
Inclusion criteria:
- Prepubertal children:
- Boys:
- Age greater than or equal to 2 years and 26 weeks and less than 11.0 years at screening
- Testis volume less than 4 mL
- Girls:
- Age greater than or equal to 2 years and 26 weeks and less than 10.0 years at screening
- Tanner stage 1 for breast development (no palpable glandular breast tissue)
- Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/mL using the world health organisation (WHO) International Somatropin 98/574 standard
- Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
- Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
- Insulin-like Growth Factor-I (IGF-I) less than -1.0 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 192
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
(ICTRP)
Exclusion criteria:
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
- Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
- Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 ?g/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
- Diagnosis of attention deficit hyperactivity disorder
- Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
- Prior history or presence of malignancy including intracranial tumours
Critères d'évaluation principaux et secondaires
Main Objective: To compare the effect of somapacitan vs Norditropin? on longitudinal growth in children with
growth hormone deficiency.;Secondary Objective: To compare the safety of somapacitan vs Norditropin? in children with growth hormone deficiency.;Primary end point(s): Height velocity;Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 7 (week 52) (ICTRP)
Secondary end point(s): 1. Change in bone age
2. Change in Height Standard Deviation Score
3. Change in Height Velocity Standard Deviation Score
4. Change in fasting plasma glucose
5. Change in homeostatic model assessment
6. Change in Glycated haemoglobin (HbA1c)
7. Change in Insulin-like growth factor I (IGF-I) Standard Deviation Score
8. Change in Insulin-like growth factor binding protein 3 (IGFBP-3) Standard Deviation Score;Timepoint(s) of evaluation of this end point: 1 & 4 ? 6: From screening (week -2) to visit 7 (week 52), visit 11 (week 104), visit 15 (week 156) and visit 19 (week 208)
2, 3, 7 & 8: From baseline (week 0) to visit 7 (week 52), visit 11 (week 104), visit 15 (week 156) and visit 19 (week 208) (ICTRP)
Date d'enregistrement
05.02.2020 (ICTRP)
Inclusion du premier participant
23.03.2020 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Clinical Disclosure (1452), clinicaltrials@novonordisk.com, Novo Nordisk A/S (ICTRP)
ID secondaires
NN8640-4263, 2018-000231-27-DE (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000231-27 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible