Short Children Born Small for Gestational Age (SGA)SGANCT01491854
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
A study testing Bloodsampling in people with Short Children Born Small for Gestational Age (SGA), run by Sandoz at 23 sites in 6 countries.
Trial summary
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan 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
- Short Children Born Small for Gestational Age (SGA)
- What is being tested?
- Bloodsampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 20 Jul 2009to 31 Oct 2018
- Phase
- Interventional
- 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
- All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
- Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian
Who cannot join
- Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Poland13 sites
Novartis Investigative Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85667
Novartis Investigative Site
Gdansk, 80 952
Novartis Investigative Site
Katowice, Silesian Voivodeship, 40-752
Novartis Investigative Site
Kielce, Świętokrzyskie Voivodeship, 25734
Novartis Investigative Site
Krakow, 30-663
Novartis Investigative Site
Lodz, 93-338
Novartis Investigative Site
Poznai, Greater Poland Voivodeship, 60-572
Novartis Investigative Site
Rzeszów, Podkarpackie Voivodeship, 35-301
Novartis Investigative Site
Szczecin, 71-252
Novartis Investigative Site
Warsaw, 04 730
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 50-311
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 50-368
Novartis Investigative Site
Zabrze, Silesian Voivodeship, 41-800
Czechia3 sites
Novartis Investigative Site
Hradec Králové, 500 05
Novartis Investigative Site
Prague, 150 06
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 11
Romania3 sites
Novartis Investigative Site
Bucharest, 20395
Novartis Investigative Site
Cluj-Napoca, CLUJ
Novartis Investigative Site
Lasi, Iaşi, 700111
Germany2 sites
Novartis Investigative Site
München, 80337
Novartis Investigative Site
Nordrhein Westfalen, Sankt Augustin, 53757
About this study
Official title: Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan 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
The purpose of this study is
- to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment and
- to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.
- Being tested
- Bloodsampling
- Keywords
- Long-term, safety, follow-up, growth hormone treatment, short children, Small for Gestational Age, Somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloodsamplingOther
Bloodsampling
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of long-term safety | Other | Long-term safety follow-up after the end of treatment with Omnitrope (single arm) Receives: Other: Bloodsampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria:
- FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT)
- 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT
- Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT
Measured: 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
Supportive to Primary Endpoint
Measured: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
Supportive to Primary Endpoint
Measured: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
Supportive to Primary Endpoint
Measured: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4).
< 1.0 means you are insulin-sensitive which is optimal. >1.9 indicates early insulin resistance. > 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance.
Measured: baseline, 6 months, 1 year, 5 years
Secondary outcomes (3)
to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment
Measured: baseline, 6 months, 1 year , 5 years
To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.
number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).
Measured: baseline, 6 months, 1 year, 5 years
to Evaluate Final Height
Measured: baseline, 6 months, 1 year, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study start20 Jul 2009
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Why it stopped: in accordance with the request to close study EP00-402 "EMEA/H/C/000607/MEA 10.2" submitted and adopted by the EMA
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 Short Children Born Small for Gestational Age (SGA)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz Biopharmaceuticals Sandoz, Study chair, Sandoz GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491854
- Sponsor's protocol ID
- CEP00-402
- Acronym
- SGA
- Status last verified
- Jul 2019
- First submitted
- 12 Dec 2011
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)
- ClinicalTrials.gov ID
- NCT01491854
- Acronym / sponsor ID
- SGA / CEP00-402
- Keywords
- Long-term, safety, follow-up, growth hormone treatment, short children, Small for Gestational Age, Somatropin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: in accordance with the request to close study EP00-402 "EMEA/H/C/000607/MEA 10.2" submitted and adopted by the EMA
- Enrolment
- 130 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Posted 14 Aug 2019
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 as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan 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
The purpose of this study is
- to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment and
- to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of long-term safety | Other | Other: BloodsamplingLong-term safety follow-up after the end of treatment with Omnitrope (single arm) |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
- Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian
Key exclusion criteria (1 listed)
- Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
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 |
|---|---|---|
| BloodsamplingBloodsampling | Other | Monitoring of long-term safety |
Primary outcome
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
Time frame: 5 years
Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria: * FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT) * 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT * Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
Time frame: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
Time frame: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
Time frame: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
Time frame: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4). < 1.0 means you are insulin-sensitive which is optimal. >1.9 indicates early insulin resistance. > 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance.
3 secondary outcomes
to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment
Time frame: baseline, 6 months, 1 year , 5 years
To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.
Time frame: baseline, 6 months, 1 year, 5 years
to Evaluate Final Height
Time frame: baseline, 6 months, 1 year, 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Sandoz study chair
Sandoz GmbH
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloodsampling in people with Short Children Born Small for Gestational Age (SGA), run by Sandoz at 23 sites in 6 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Poland, Czechia, Romania, Germany, Georgia and 1 more country. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). 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?
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy. (time frame: 5 years). The study lists 5 primary outcomes in all. 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 14 Aug 2019.