Small for Gestational AgePhase 4NCT00537914
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
A Phase 4 study testing Omnitrope in people with Small for Gestational Age, run by Sandoz at 31 sites in 7 countries.
Trial summary
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Small for Gestational Age
- What is being tested?
- Omnitrope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 6 Feb 2008to 25 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
- Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
- Birth weight and/or length below -2 standard deviations (SD) for gestational age
Who cannot join
- Onset of puberty
- Closed epiphyses
- Diabetes mellitus type I or type II
- Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
- Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
- Known IGF-I level above +2SD for sex and age
Show all 10Show fewer
- Acute critical illness
- Previous treatment with any hGH preparation
- Treatment with antidiabetic medication (e.g. metformin, insulin)
- Drug abuse, substance abuse, or alcohol abuse
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
Poland14 sites
Sandoz Investigational Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-667
Sandoz Investigational Site
Gdansk, 80-952
Sandoz Investigational Site
Katowice, Silesian Voivodeship, 40-752
Sandoz Investigational Site
Katowice, 40-752
Sandoz Investigational Site
Kielce, Świętokrzyskie Voivodeship, 25734
Sandoz Investigational Site
Krakow, 30-663
Sandoz Investigational Site
Lodz, 93-338
Sandoz Investigational Site
Poznan, Greater Poland Voivodeship, 60-572
Sandoz Investigational Site
Rzeszów, Podkarpackie Voivodeship, 35-301
Sandoz Investigational Site
Szczecin, 71-252
Sandoz Investigational Site
Warsaw, 04-730
Sandoz Investigational Site
Wroclaw, Lower Silesian Voivodeship, 50-368
Sandoz Investigational Site
Wroclaw, 51-312
Sandoz Investigational Site
Zabrze, Silesian Voivodeship, 41-800
Hungary5 sites
Sandoz Investigational Site
Budapest, 1023
Sandoz Investigational Site
Budapest, 1094
Sandoz Investigational Site
Győr, 9024
Sandoz Investigational Site
Miskolc, 3526
Sandoz Investigational Site
Szeged, Csongrád megye, 6720
Romania5 sites
Sandoz Investigational Site
Bucharest, 011461
Sandoz Investigational Site
Bucharest, 020395
Sandoz Investigational Site
Cluj-Napoca, Cluj, 400370
Sandoz Investigational Site
Craiova, 200642
Sandoz Investigational Site
Iași, 700111
Czechia3 sites
Sandoz Investigational Site
Hradec Králové, 500 05
Sandoz Investigational Site
Prague, Prague, 150 06
Sandoz Investigational Site
Ústí nad Labem, 400 11
Germany2 sites
Sandoz Investigational Site
Munich, Bavaria, 80337
Sandoz Investigational Site
Sankt Augustin, North Rhine-Westphalia, 53757
About this study
Official title: Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
Read the detailed description
Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.
- Conditions
- Small for Gestational Age
- Being tested
- Omnitrope
- Keywords
- Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnitropeDrug
Also called Somatropin
All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.
| Study group | Role | What they receive |
|---|---|---|
| Omnitrope | Experimental | All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. Receives: Drug: Omnitrope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.
Measured: throughout the study, approximately 13 years
Secondary outcomes (7)
Mean Change in Height (H) (cm) From Baseline
Mean change in Height from baseline for all patients was reported.
Measured: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in Height Standard Deviation Score Over Time From Baseline
SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table.
In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the catch-up growth over time towards average normal growth starting from below average.
Measured: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
Mean change in Height velocity (HV) (cm/year) over time from baseline was reported.
Measured: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table.
In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the initial high increase in height velocity which remains positive over years, but is decreasing over time.
Measured: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
Mean change in serum IGF-1 level (nmol/L) from baseline was reported.
Measured: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
Mean change in IGFBP-3 levels (nmol/L) from baseline was reported.
Measured: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment
Number of participants with the development of anti-rhGH antibodies with positive test result were reported.
Measured: throughout the study, approximately 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study start6 Feb 2008
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small for Gestational AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz Biopharmaceuticals, Study chair, Sandoz GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537914
- Sponsor's protocol ID
- CEP00-401
- Other IDs
- 2006-002506-58
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2007
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
- ClinicalTrials.gov ID
- NCT00537914
- Acronym / sponsor ID
- CEP00-401
- Conditions
- Small for Gestational Age
- Keywords
- Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2008 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
Detailed description
Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omnitrope | Experimental | Drug: OmnitropeAll enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
- Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
- Birth weight and/or length below -2 standard deviations (SD) for gestational age
Key exclusion criteria (10 listed)
- Onset of puberty
- Closed epiphyses
- Diabetes mellitus type I or type II
- Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
- Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnitropeAlso: SomatropinAll enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits. | Drug | Omnitrope |
Primary outcome
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment
Time frame: throughout the study, approximately 13 years
The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.
7 secondary outcomes
Mean Change in Height (H) (cm) From Baseline
Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in Height Standard Deviation Score Over Time From Baseline
Time frame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline
Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline
Time frame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years
Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline
Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline
Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years
Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment
Time frame: throughout the study, approximately 13 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Related trials for Small for Gestational Age
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingPhase 2
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Short Stature Children Born Small for Gestational Age (SGA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz Biopharmaceuticals study chair
Sandoz GmbH
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omnitrope in people with Small for Gestational Age, run by Sandoz at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Poland, Hungary, Romania, Czechia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment (time frame: throughout the study, approximately 13 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.