A study comparing the effect and safety of once-weekly dosing of Somapacitan with daily administered Norditropin® in children with growth hormone deficiency.

Algeria, Austria, Canada, Denmark, Estonia, European Union, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Norway, Poland, Russian Federation, Serbia, Slovenia, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States (ICTRP)

ID di studio ICTRP
EUCTR2018-000231-27 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin? in children with growth hormone deficiency - REAL4 (ICTRP)

Titolo pubblico
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)

Malattie studiate
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)

Intervento studiato

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)

Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)

Disegno dello studio
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)

Criteri di inclusione/esclusione
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


Endpoint primari e secondari
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)

Data di registrazione
05.02.2020 (ICTRP)

Inclusione del primo partecipante
23.03.2020 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Clinical Disclosure (1452), clinicaltrials@novonordisk.com, Novo Nordisk A/S (ICTRP)

ID secondari
NN8640-4263, 2018-000231-27-DE (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000231-27 (ICTRP)