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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03811535




Registration number
NCT03811535
Ethics application status
Date submitted
18/01/2019
Date registered
22/01/2019

Titles & IDs
Public title
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 (REAL4)
Scientific title
A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
Secondary ID [1] 0 0
U1111-1207-9691
Secondary ID [2] 0 0
NN8640-4263
Universal Trial Number (UTN)
Trial acronym
REAL4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Deficiency in Children 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Somapacitan
Treatment: Drugs - Norditropin®

Experimental: Somapacitan weekly - Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).

Active comparator: Norditropin® daily - Participants will receive Norditropin® daily for 52 weeks (main trial period).


Treatment: Drugs: Somapacitan
Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Treatment: Drugs: Norditropin®
Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Height Velocity: In-trial Observation Period
Timepoint [1] 0 0
From baseline (week 0) to visit 7 (week 52)
Primary outcome [2] 0 0
Height Velocity: On-treatment Observation Period
Timepoint [2] 0 0
From baseline (week 0) to visit 7 (week 52)
Secondary outcome [1] 0 0
Change in Bone Age
Timepoint [1] 0 0
Baseline (week -2), week 52
Secondary outcome [2] 0 0
Change in Height Standard Deviation Score (HSDS)
Timepoint [2] 0 0
Baseline (week 0), week 52
Secondary outcome [3] 0 0
Change in Height Velocity Standard Deviation Score (HV SDS)
Timepoint [3] 0 0
Baseline (week 0), week 52
Secondary outcome [4] 0 0
Change in Fasting Plasma Glucose (FPG) at Week 52
Timepoint [4] 0 0
Baseline (week -2), week 52
Secondary outcome [5] 0 0
Change in FPG at Week 104
Timepoint [5] 0 0
Baseline (week -2), week 104
Secondary outcome [6] 0 0
Change in FPG at Week 156
Timepoint [6] 0 0
Baseline (week -2), week 156
Secondary outcome [7] 0 0
Change in FPG at Week 208
Timepoint [7] 0 0
Baseline (week -2), week 208
Secondary outcome [8] 0 0
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52
Timepoint [8] 0 0
Baseline (week -2), week 52
Secondary outcome [9] 0 0
Change in HOMA-B at Week 104
Timepoint [9] 0 0
Baseline (week -2), week 104
Secondary outcome [10] 0 0
Change in HOMA-B at Week 156
Timepoint [10] 0 0
Baseline (week -2), week 156
Secondary outcome [11] 0 0
Change in HOMA-B at Week 208
Timepoint [11] 0 0
Baseline (week -2), week 208
Secondary outcome [12] 0 0
Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52
Timepoint [12] 0 0
Baseline (week -2), week 52
Secondary outcome [13] 0 0
Change in HOMA-IR at Week 104
Timepoint [13] 0 0
Baseline (week -2), week 104
Secondary outcome [14] 0 0
Change in HOMA-IR at Week 156
Timepoint [14] 0 0
Baseline (week -2), week 156
Secondary outcome [15] 0 0
Change in HOMA-IR at Week 208
Timepoint [15] 0 0
Baseline (week -2), week 208
Secondary outcome [16] 0 0
Change in Glycated Haemoglobin (HbA1c) at Week 52
Timepoint [16] 0 0
Baseline (week -2), week 52
Secondary outcome [17] 0 0
Change in HbA1c at Week 104
Timepoint [17] 0 0
Baseline (week -2), week 104
Secondary outcome [18] 0 0
Change in HbA1c at Week 156
Timepoint [18] 0 0
Baseline (week -2), week 156
Secondary outcome [19] 0 0
Change in HbA1c at Week 208
Timepoint [19] 0 0
Baseline (week -2), week 208
Secondary outcome [20] 0 0
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52
Timepoint [20] 0 0
Baseline (week 0), week 52
Secondary outcome [21] 0 0
Change in IGF-I SDS at Week 104
Timepoint [21] 0 0
Baseline (week 0), week 104
Secondary outcome [22] 0 0
Change in IGF-I SDS at Week 156
Timepoint [22] 0 0
Baseline (week 0), week 156
Secondary outcome [23] 0 0
Change in IGF-I SDS at Week 208
Timepoint [23] 0 0
Baseline (week 0), week 208
Secondary outcome [24] 0 0
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52
Timepoint [24] 0 0
Baseline (week 0), week 52
Secondary outcome [25] 0 0
Change in IGFBP-3 SDS at Week 104
Timepoint [25] 0 0
Baseline (week 0), week 104
Secondary outcome [26] 0 0
Change in IGFBP-3 SDS at Week 156
Timepoint [26] 0 0
Baseline (week 0), week 156
Secondary outcome [27] 0 0
Change in IGFBP-3 SDS at Week 208
Timepoint [27] 0 0
Baseline (week 0), week 208

Eligibility
Key inclusion criteria
* Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more 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 SDS at screening, compared to age and gender normalized range measured at central laboratory
* No prior exposure to growth hormone therapy or IGF-I treatment
Minimum age
No limit
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Algeria
State/province [19] 0 0
Algiers
Country [20] 0 0
Algeria
State/province [20] 0 0
Constantine
Country [21] 0 0
Austria
State/province [21] 0 0
Graz
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
St. Poelten
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
France
State/province [25] 0 0
Angers
Country [26] 0 0
France
State/province [26] 0 0
Bordeaux
Country [27] 0 0
France
State/province [27] 0 0
Le Kremlin-Bicetre
Country [28] 0 0
France
State/province [28] 0 0
Le Kremlin-bicetre
Country [29] 0 0
France
State/province [29] 0 0
MARSEILLE Cédex 05
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
Germany
State/province [31] 0 0
Frankfurt am Main
Country [32] 0 0
Germany
State/province [32] 0 0
Tübingen
Country [33] 0 0
India
State/province [33] 0 0
Kerala
Country [34] 0 0
India
State/province [34] 0 0
Maharashtra
Country [35] 0 0
India
State/province [35] 0 0
New Delhi
Country [36] 0 0
Ireland
State/province [36] 0 0
Dublin
Country [37] 0 0
Israel
State/province [37] 0 0
Haifa
Country [38] 0 0
Israel
State/province [38] 0 0
Kfar Saba
Country [39] 0 0
Israel
State/province [39] 0 0
Petah Tikva
Country [40] 0 0
Israel
State/province [40] 0 0
Zerifin
Country [41] 0 0
Italy
State/province [41] 0 0
Firenze
Country [42] 0 0
Italy
State/province [42] 0 0
Roma
Country [43] 0 0
Japan
State/province [43] 0 0
Fukuoka-shi, Fukuoka
Country [44] 0 0
Japan
State/province [44] 0 0
Fukuyama-shi, Hiroshima
Country [45] 0 0
Japan
State/province [45] 0 0
Kyoto
Country [46] 0 0
Japan
State/province [46] 0 0
Mito, Ibaraki
Country [47] 0 0
Japan
State/province [47] 0 0
Nara-shi, Nara
Country [48] 0 0
Japan
State/province [48] 0 0
Obu-shi, Aichi
Country [49] 0 0
Japan
State/province [49] 0 0
Okayama-shi, Okayama
Country [50] 0 0
Japan
State/province [50] 0 0
Osaka
Country [51] 0 0
Japan
State/province [51] 0 0
Shizuoka
Country [52] 0 0
Japan
State/province [52] 0 0
Suita-shi, Osaka
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Busan
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Daegu
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Gyeonggi-do
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul
Country [58] 0 0
Latvia
State/province [58] 0 0
Riga
Country [59] 0 0
Poland
State/province [59] 0 0
Szczecin
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Izhevsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Moscow
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Novosibirsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Rostov-on-Don
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint-Petersburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Samara
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Tomsk
Country [68] 0 0
Serbia
State/province [68] 0 0
Belgrade
Country [69] 0 0
Serbia
State/province [69] 0 0
Novi Sad
Country [70] 0 0
Slovenia
State/province [70] 0 0
Ljubljana
Country [71] 0 0
Spain
State/province [71] 0 0
A Coruña
Country [72] 0 0
Spain
State/province [72] 0 0
Esplugues Llobregat(Barcelona)
Country [73] 0 0
Switzerland
State/province [73] 0 0
Bern
Country [74] 0 0
Thailand
State/province [74] 0 0
Bangkok
Country [75] 0 0
Ukraine
State/province [75] 0 0
Kharkiv
Country [76] 0 0
Ukraine
State/province [76] 0 0
Kyiv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Vinnytsia
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Cambridge
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Hull
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Liverpool
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Manchester
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.novonordisk-trials.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03811535