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. |
Register:
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EUCTR |
Last refreshed on:
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15 November 2021 |
Main ID: |
EUCTR2015-000531-32-SE |
Date of registration:
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04/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in pre-pubertal children with growth hormone deficiency previously untreated with growth hormone
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Scientific title:
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A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency |
Date of first enrolment:
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14/01/2016 |
Target sample size:
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75 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000531-32 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: 3 treatment periods, 2 controlled and 1 where all patients receive once-weekly trial drug If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4
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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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Austria
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Belgium
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Brazil
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European Union
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Germany
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India
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Israel
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Japan
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Slovenia
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Sweden
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Turkey
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Ukraine
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsværd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: Cohort I:
• Pre-pubertal children
- Boys: Tanner stage 1 for pubic hair and testis volume < 4 ml, age = 2 years and 26 weeks and = 10.0 years at screening
- Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age = 2 years and 26 weeks and = 9.0 years at screening
• Confirmed diagnosis of GHD within 12 months prior to screening as determined by two different GH stimulation tests, defined as a peak GH level of =7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed.
• No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment.
• Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening.
• Annualized height velocity (HV) at screening below the 25th percentile for CA and gender or below -0.7 SD score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
Cohort II:
- < 2 years and 26 weeks and a minimum weight of 5 kg at screening.
- Confirmed diagnosis of GHD, the GHD diagnosis must be confirmed by investigator
according to local practice.
- For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-I
treatment.
- For GH treatment naïve subjects, IGF-I SDS < -1.0 at screening, compared to age and sex
normalized range according to central laboratory measurements.
Cohort III:
Age:
- Girls: > 9 years and = 17 years at screening.
- Boys: > 10 years and = 17 years at screening.
- Confirmed diagnosis of GHD:
a) for GH treatment naïve subjects, confirmed diagnosis within 12 months prior to
screening as determined by two different GH stimulation tests, defined as a peak GH
level of = 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only
one GH stimulation test is needed.
b) for non-GH treatment naïve subjects, confirmed GHD diagnosis by investigator
according to local practice
- For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-I treatment.
- Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for
males. Are the trial subjects under 18? yes Number of subjects for this age range: 75 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: Cohort I, II and III:
• Any clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing/length measurements:
- Chromosomal aneuploidy and significant gene mutations causing medical “syndromes” with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors.
- Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias.
- Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
• Children born small for gestational age (SGA - birth weight and/or birth length < -2 SD for gestational age).
• Concomitant administration of other treatments that may have an effect on growth (not applicable to non-GH treatment naïve subjects in cohort II and III), including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
• Prior history or presence of malignancy and/or intracranial tumour.
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 in children MedDRA version: 20.0
Level: PT
Classification code 10056438
Term: Growth hormone deficiency
System Organ Class: 10014698 - Endocrine disorders
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Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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Intervention(s)
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Product Code: NNC0195-0092 5 mg/1.5 ml PDS290-10 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3.3-
Product Code: NNC0195-0092 10 mg/1.5 ml PDS290-10 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.7-
Product Code: NNC0195-0092 15 mg/1.5 ml PDS290-15 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 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 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-
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Primary Outcome(s)
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Main Objective: Cohort I: To evaluate the efficacy of multiple dose regimens of once-weekly NNC0195-0092 after 26 weeks of treatment in GH treatment naïve pre-pubertal children with GHD compared to once-daily hGH administration (Norditropin® FlexPro®)
Cohort II and III: To evaluate the safety of once-weekly NNC0195-0092 during at least 13 weeks and up to 208 weeks of treatment in children with GHD.
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Secondary Objective: Cohort I: • To evaluate the safety of multiple dose regimens of once-weekly NNC0195-0092 during 26 weeks of treatment in GH treatment naïve pre-pubertal children with GHD. • To evaluate the efficacy and safety of multiple dose regimens of once-weekly NNC0195- 0092 for up to 364 weeks of treatment in GH treatment naïve pre-pubertal children with GHD compared to Norditropin® FlexPro®. • To investigate the impact of NNC0195-0092 relative to Norditropin® FlexPro® on wellbeing, psychosocial functioning and treatment satisfaction in GH treatment naïve prepubertal children with GHD. • To monitor NNC0195-0092 and Norditropin® PK throughout the trial.
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Timepoint(s) of evaluation of this end point: Cohort I: At baseline and after 26 weeks
Cohort II and III: During at least 13 weeks and up to 208 weeks of treatment
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Primary end point(s): Cohort I: Height velocity (HV) (cm/year) during first 26 week of treatment, measured as standing height with stadiometer
Cohort II and III: Incidence of adverse events, including injection site reactions in children with GHD.
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Secondary Outcome(s)
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Secondary end point(s): Cohort I:
Efficacy
Changes in the following variables will be used to address the primary objective:
1. Height standard deviation score (SDS)
2. HV SDS
Safety
The following endpoints will be used to support the secondary objectives of evaluation of safety:
3. Incidence of adverse events, including injection site reactions
4. Occurrence of anti-NNC0195-0092 and anti-hGH antibodies
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Timepoint(s) of evaluation of this end point: 1. + 2.: From baseline to end of main trial period (week 26)
3. + 4.: up to 364 weeks of treatment
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Secondary ID(s)
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2015-000531-32-AT
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NN8640-4172
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Ethics review
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Status: Approved
Approval date: 14/01/2016
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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