| CTRI Number |
CTRI/2016/09/007301 [Registered on: 23/09/2016] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to Investigate the Efficacy and Safety of Once-weekly treatment of NNC0195-0092 Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal children diagnosed With Growth Hormone Deficiency |
|
Scientific Title of Study
|
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 naive pre-pubertal children with growth hormone deficiency. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| 2015-000531-32 |
EudraCT |
| NN8640-4172 ver 7.0 dated 19 Dec 2018 |
Protocol Number |
| U1111-1166-7062 |
UTN |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President -Clinical, Medical, Regulatory & Pharmacovigilance. |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Ltd.
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore-560045
Karnataka
Novo Nordisk India Private Ltd.
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
08041123517 |
| Email |
yrms@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Maya Sharma |
| Designation |
Vice President, CMR |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Ltd.
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Karnataka
Novo Nordisk India Private Ltd.
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
08041123517 |
| Email |
yrms@novonordisk.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
Modification(s)
|
| Name |
Novo Nordisk India Private Limited |
| Address |
: Nxt Tower - 2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli,Bangalore - 560045. India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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Austria
Brazil
Germany
Turkey
India
Ireland
Slovenia
Ukraine |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Khadgawat |
All India Institute of Medical Sciences, New Delhi |
Dept of Endocrinology & Metabolism, Room no.303, Biotechnology block 3rd floor, All India Institute of Medical Sciences New Delhi 110029 India
New Delhi
DELHI
New Delhi
DELHI |
01126593237
rajeshkhadgawat@hotmail.com |
| Dr Praveen Valliyaparambil Pavithran |
Amrita Institute of Medical Sciences & Research Centre |
Ground Floor, A Block, Endocrinology department, Room no.11 Amrita Institute of Medical Sciences & Research Centre AIMS-Ponekkara. P.O, Kochi Kerala 682041
Ernakulam
KERALA
Ernakulam
KERALA |
919495247676
914842802131
praveenvp@aims.amrita.edu |
| Dr Khadilkar Vaman Vasant |
Jehangir Clinical Development Centre |
Jehangir clinical
development
centre,Jehangir
Hospital Premises,32, Sassoon Road,Pune,
Maharashtra-411001.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9860027285
vaman.khadilkar@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt Ltd, Dr. Vaman Khadilkar |
Approved |
| Ethics Committee, AIIMS, New Delhi , Dr Rajesh Khadgawat |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical and Research Centre, Dr Praveen Valliyaparambil Pavithran |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, Growth Hormone Disorder
Growth Hormone Deficiency in Children, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blinded NNC0195-0092 (0.04 mg/kg/week) |
NNC0195-0092
Administered subcutaneously (s.c., under the
skin) once-weekly
Period:52 Weeks |
| Intervention |
Blinded NNC0195-0092 (0.08 mg/kg/
week) |
NNC0195-0092
Administered subcutaneously (s.c., under the
skin) once-weekly.
Period: 52 weeks |
| Intervention |
Blinded NNC0195-0092 (0.16 mg/kg/
week) |
NNC0195-0092
Administered subcutaneously (s.c., under the
skin) once-weekly.
Period: 52 weeks |
| Comparator Agent |
Open labelled daily Norditropin®
(0.034 mg/kg/day) |
Norditropin® FlexPro® pen
Administered subcutaneously (s.c., under the
skin) once daily
period:52 Weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
For an eligible subject, all inclusion criteria must be answered “yesâ€.
1. Informed consent of parent or legally acceptable representative (LAR) of subject and child
assent, as age-appropriate obtained before any trial-related activities. Trial-related activities are
any procedures that are carried out as part of the trial, including activities to determine
suitability for the trial.
a. The parent or LAR of the child must sign and date the Informed Consent Form
(according to local requirements).
b. The child must sign and date the Child Assent Form or provide oral assent (if required
according to local requirements).
2. Pre-pubertal children
o Boys: Tanner stage 1 for pubic hair and testis volume < 4 mL 1, age ≥ 2 years and 26
weeks and ≤ 10.0 years.
o Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue)
and pubic hair 1, age ≥ 2 years and 26 weeks and ≤ 9.0 years.
3. 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.
FOR JAPAN ONLY: Confirmed diagnosis of GHD within 12 months prior to screening as
determined by one GH stimulation tests for patients with intracranial organic disease or
symptomatic hypoglycaemia and two different GH stimulation test for other patients, defined as
a peak GH level of ≤ 6 ng/ml by assay using recombinant GH standard. END OF TEXT
ONLY APPLICABLE FOR JAPAN.
4. No prior exposure to GH therapy and/or IGF-I treatment.
5. 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 (CDC)
2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC 2 at screening.
6. 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 3 calculated over a
time span of minimum 6 months and maximum 18 months prior to screening.
7. Body Mass Index (BMI) percentile >5th and <95th percentile according to Centers for Disease
Control and Prevention (CDC)2 BMI-for-age growth charts.
8. IGF-I SDS < -1.0 at screening, compared to age and sex normalized range according to central
laboratory measurements.
9. Bone age (X-ray of left hand and wrist, central reviewed according to Greulich & Pyle atlas19)
less than chronological age at screening. An X-ray taken within 13 weeks prior to screening can
be used as screening data if the image is available and meets requirements for central reading. |
|
| ExclusionCriteria |
| Details |
For an eligible subject, all exclusion criteria must be answered "no".
1. Previous participation in this trial. Participation is defined as randomisation.
2. Receipt of any investigational medicinal product within 3 months before screening.
FOR BRAZIL ONLY: Participation in other trials within one year (defined as 365 days) prior
to screening visit (Visit 1) unless there is a direct benefit to the research subject at the
investigator´s discretion. END OF TEXT ONLY APPLICABLE FOR BRAZIL
3. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth
with standing measurements:
ï‚· Chromosomal aneuploidy and significant gene mutations causing medical “syndromesâ€
with short stature, including but not limited to Turner syndrome, Laron syndrome,
Noonan syndrome, or absence of GH receptors.
ï‚· Congenital abnormalities (causing skeletal abnormalities), including but not limited to
Russell-Silver Syndrome, skeletal dysplasia.
ï‚· Significant spinal abnormalities including but not limited to scoliosis, kyphosis and
spina bifida variants.
4. Poorly controlled or uncontrolled pituitary insufficiencies or primary hormonal deficiencies of
other axes (e.g., thyroid-stimulating hormone/T4, adrenocorticotropic hormone/cortisol, and
vasopressin deficiency) in children who have been on stable replacement therapy for less than 6
months for thyroid replacement therapy, and less than 3 months for other hormonal deficiencies
prior to screening.
5. Children born small for gestational age (SGA - birth weight and/or birth length < -2 SD for
gestational age).
6. Children diagnosed with diabetes mellitus or fasting blood glucose ≥126 mg/dl (7.0 mmol/L), or
HbA1c ≥ 6.5% at screening, determined by central laboratory.
7. Current inflammatory diseases (e.g. but not limited to arthritis, inflammatory bowel diseases)
requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3
months prior to screening.
8. Children requiring inhaled glucocorticoid therapy (e.g. asthma) 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.
9. 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 (ADHD).
10. Prior history or presence of malignancy and/or intracranial tumour.
11. Prior history or presence of active Hepatitis B and/or Hepatitis C (exceptions to this exclusion
criterion is the presence of antibodies due to vaccination against Hepatitis B and Hepatitis C).
12. Clinically significant abnormal ECG at screening, as evaluated by investigator.
13. Any clinically significant abnormal laboratory screening tests, as judged by the investigator
14. Any disorder which, in the opinion of the investigator, might jeopardise subject’s safety or
compliance with the protocol.
15. The subject and/or the parent/LAR are likely to be non-compliant in respect to trial conduct, as judged by the investigator. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Height velocity (HV) (cm/year) during the first 26 weeks of treatment, measured as standing height with stadiometer |
Week 0 to Week 26 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in height standard deviation score (SDS) |
Week 0,Week 26 |
| Change in HV (height velocity) SDS |
Week 0 to Week 26 |
| Incidence of adverse events, including injection site reactions |
At Week 26
At week 52
At week 53 |
| Occurrence of anti-NNC0195-0092 and anti-hGH antibodies |
At Week 26
At week 52
At week 53 |
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Target Sample Size
Modification(s)
|
Total Sample Size="76"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="14" |
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Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
13/10/2016 |
| Date of Study Completion (India) |
06/12/2024 |
| Date of First Enrollment (Global) |
23/03/2016 |
| Date of Study Completion (Global) |
06/12/2024 |
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Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïe pre-pubertal children with growth hormone deficiency.
The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period. |