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SNCTP000003332 | EUCTR2018-000231-27 | BASEC2019-00311

Eine Studie, in der die Wirkung und Sicherheit der einmal wöchentlichen Dosierung von Somapacitan mit dem täglich verabreichten Norditropin® bei Kindern mit Wachstumshormonmangel verglichen wird.

Data source: BASEC (Imported from 14.04.2021), WHO (Imported from 11.04.2021)
Changed: 11.04.2021
Disease category: Endocrinological diseases (non cancer)

Brief description of trial (Data source: BASEC)

In dieser Studie wird das Studienmedikament Somapacitan mit dem täglich angewendeten Norditropin verglichen, um die Sicherheit und Wirksamkeit bei Kindern mit Wachstumshormonmangel zu beurteilen. Somapacitan ist ein langwirksames Wachstumshormon, dass nur einmal pro Woche subkutan gespritzt werden muss, wohingegen Norditropin 1x pro Tag subkutan gespritzt werden muss.
Insgesamt werden 192 Patienten nach dem Zufallsprinzip von einem Computersystem im Verhältnis 2:1 einem der beiden Prüfpräparate – Somapacitan (Wachstumshormon einmal pro Woche) oder Norditropin® (Wachstumshormon einmal pro Tag) – zugeteilt. Die Studie ist nicht verblindet, das heisst sowohl der Patient selbst wie auch das Personal des Prüfzentrums werden wissen, welche Behandlung der Patient bekommt. In der Schweiz sind 8 Patienten in 3 Prüfzentren geplant.
Es handelt sich um eine internationale Studie, welche in mehreren Studienzentren weltweit durchgeführt wird.

Health conditions investigated (Data source: BASEC)

Wachstumshormonmangel

Health conditions (Data source: WHO)

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]

Rare disease (Data source: BASEC)

Yes

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Die gesamte Studiendauer beträgt für den einzelnen Patienten 4 Jahre.

Die Studie umfasst eine Screeningphase von ungefähr einer Woche, in der entschieden wird ob die Patienten für die Studie in Frage kommen. Geeignete Patienten beginnen danach eine 52 wöchige Phase, in der sie zufällig auf das Studienmedikament Somapacitan oder die Standardtherapie mit Norditropin eingeteilt werden. In der daraufolgenden 3 Jahre werden alle Studienpatienten mit Somapacitan behandelt um mehr Daten zur Behandlung und deren Sicherheit zu sammeln.

Insgesamt beinhaltet die Studie 19 Besuche am Studienzentrum und 1 Telefonkontakt mit dem Prüfarzt innerhalb von 4 Jahren.

Während den Visiten am Studienzentrum werden verschiedene Untersuchungen (z.B. Röntgen der Hand, Grösse, Gewicht, EKG) gemacht, sowie Blutproben entnommen.

Interventions (Data source: WHO)


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-

Criteria for participation in trial (Data source: BASEC)

Die Haupteinschlusskriterien sind:
1. Vorpubertäre Kinder:
- Knaben zwischen 2 1/2 Jahren und 11 Jahren
- Mädchen zwischen 2 1/2 Jahren und 10 Jahren
2. Bestätigte Diagnose eines Wachstumshormonmangels, der durch zwei verschiedene Wachstumshormon Stimulationstests bestimmt wurde, die innerhalb von 12 Monaten vor dem Studieneinschluss durchgeführt wurden.
3. Keine schon durchgeführte Therapie mit Wachstumshormonen oder einem insulinähnlichen Wachstumsfaktor-I (IGF-I) .

Exclusion criteria (Data source: BASEC)

Die Hauptausschlusskriterien sind:
1. Jede bekannte oder vermutete klinisch signifikante Anomalie, die das Wachstum oder das Wachstum beeinträchtigen könnte.
2. Einnahme von Medikamenten, die einen Einfluss auf das Wachstum haben können.
3. Diagnose einer Aufmerksamkeitsdefizit Hyperaktivitätsstörung (ADHS)

Inclusion/Exclusion Criteria (Data source: WHO)

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 µg/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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000231-27

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2018-000231-27-AT

Further information on trial

Date trial registered

02.04.2019

Incorporation of the first participant

22.05.2019

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency - REAL4

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

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)

Secundary end point (Data source: WHO)

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)

Contact information (Data source: WHO)

Novo Nordisk A/S

Trial results (Data source: WHO)

Results summary

A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bern, Zurich

Countries (Data source: WHO)

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

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Maddalena Ghielmetti
+41 44 914 11 11
mdlg@novonordisk.com

Contact for general information (Data source: WHO)

Clinical Disclosure (1452)
Novo Allé
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Contact for scientific information (Data source: WHO)

Clinical Disclosure (1452)
Novo Allé
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novo Nordisk A/S

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

07.05.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-00311

Secondary ID (Data source: WHO)

NN8640-4263
2018-000231-27-DE