Who is sponsoring NCT01491854?

NCT01491854 is sponsored by Sandoz.

What drugs are being tested in NCT01491854?

Interventions in NCT01491854: Bloodsampling.

What condition does NCT01491854 study?

NCT01491854 studies Short Children Born Small for Gestational Age (SGA).

Is NCT01491854 still recruiting?

NCT01491854 is currently terminated. Last updated 14 August 2019.

Are results published for NCT01491854?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-14 · How we verify

NCT01491854: SGA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

Terminated NA Results posted Last updated 14 August 2019

What this trial tests

NA trial testing Bloodsampling in Short Children Born Small for Gestational Age (SGA) in 130 participants. Terminated before completion.

Timeline

20 July 2009

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Sandoz
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	130
Start date	20 July 2009
Primary completion	31 October 2018
Estimated completion	31 October 2018
Sites	23 locations across Georgia, Germany, Poland, Hungary, Romania, Czechia

Drugs / interventions tested

Bloodsampling

Conditions studied

Short Children Born Small for Gestational Age (SGA) — all drugs for Short Children Born Small for Gestational Age (SGA) →

Sponsor

Sandoz — full company profile →

Who can join

4 and older, any sex, with Short Children Born Small for Gestational Age (SGA). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy. Primary · 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

Group	Value	95% CI
Monitoring of Long-term Safety	0

to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment Secondary · baseline, 6 months, 1 year , 5 years

IGF-1 baseline

Group	Value	95% CI
Monitoring of Long-term Safety	67.42	± 31.137

IGF-1 6 months

Group	Value	95% CI
Monitoring of Long-term Safety	48.42	± 20.002

IGF-1 1 year

Group	Value	95% CI
Monitoring of Long-term Safety	46.28	± 21.555

IGF-1 5 years

Group	Value	95% CI
Monitoring of Long-term Safety	44.60	± 16.035

IGFBP-3 baseline

Group	Value	95% CI
Monitoring of Long-term Safety	211.12	± 49.523

IGFBP-3 6 months

Group	Value	95% CI
Monitoring of Long-term Safety	187.79	± 42.999

IGFBP-3 1 year

Group	Value	95% CI
Monitoring of Long-term Safety	186.59	± 47.246

IGFBP-3 5 years

Group	Value	95% CI
Monitoring of Long-term Safety	180.00	± 26.470

To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment. Secondary · baseline, 6 months, 1 year, 5 years

number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).

baseline

Group	Value	95% CI
Monitoring of Long-term Safety	0

6 months

Group	Value	95% CI
Monitoring of Long-term Safety	1

1 year

Group	Value	95% CI
Monitoring of Long-term Safety	0

5 years

Group	Value	95% CI
Monitoring of Long-term Safety	0

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels Primary · baseline, 6 months, 1 year, 5 years

Supportive to Primary Endpoint

FPG baseline

Group	Value	95% CI
Monitoring of Long-term Safety	4.69	± 0.492

FPG 6 months

Group	Value	95% CI
Monitoring of Long-term Safety	-0.13	± 0.567

FPG 1 year

Group	Value	95% CI
Monitoring of Long-term Safety	-0.14	± 0.457

FPG 5 years

Group	Value	95% CI
Monitoring of Long-term Safety	-0.37	± 0.856

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels Primary · baseline, 6 months, 1 year, 5 years

Supportive to Primary Endpoint

baseline

Group	Value	95% CI
Monitoring of Long-term Safety	70.87	± 38.477

6 months

Group	Value	95% CI
Monitoring of Long-term Safety	-2.34	± 38.267

1 year

Group	Value	95% CI
Monitoring of Long-term Safety	-7.48	± 34.676

5 years

Group	Value	95% CI
Monitoring of Long-term Safety	3.40	± 52.526

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c) Primary · baseline, 6 months, 1 year, 5 years

Supportive to Primary Endpoint

baseline

Group	Value	95% CI
Monitoring of Long-term Safety	5.280	± 0.3569

6 months

Group	Value	95% CI
Monitoring of Long-term Safety	-0.057	± 0.3621

1 year

Group	Value	95% CI
Monitoring of Long-term Safety	-0.108	± 0.2931

5 years

Group	Value	95% CI
Monitoring of Long-term Safety	-0.308	± 0.6036

to Evaluate Final Height Secondary · baseline, 6 months, 1 year, 5 years

baseline

Group	Value	95% CI
Monitoring of Long-term Safety	152.63	± 16.362

6 months

Group	Value	95% CI
Monitoring of Long-term Safety	152.41	± 16.894

1 year

Group	Value	95% CI
Monitoring of Long-term Safety	152.43	± 16.698

5 years

Group	Value	95% CI
Monitoring of Long-term Safety	150.42	± 12.938

To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores Primary · 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 resis

HOMA score baseline

Group	Value	95% CI
Monitoring of Long-term Safety	2.082	± 1.0336

HOMA score 6 months

Group	Value	95% CI
Monitoring of Long-term Safety	-0.073	± 1.1447

HOMA score 1 year

Group	Value	95% CI
Monitoring of Long-term Safety	-0.206	± 1.0170

HOMA score 5 years

Group	Value	95% CI
Monitoring of Long-term Safety	0.094	± 1.8835

QUICKI score baseline

Group	Value	95% CI
Monitoring of Long-term Safety	0.354	± 0.0459

QUICKI score 6 months

Group	Value	95% CI
Monitoring of Long-term Safety	0.004	± 0.0350

QUICKI score 1 year

Group	Value	95% CI
Monitoring of Long-term Safety	0.012	± 0.0413

QUICKI score 5 years

Group	Value	95% CI
Monitoring of Long-term Safety	0.022	± 0.0703

Adverse events — posted to ClinicalTrials.gov

Time frame: approximately 9 years. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Total

Serious: 8/118 (7%)

Deaths: 1/118

Serious adverse events (16 terms)

Reaction	System	Total
Syncope	Nervous system disorders	—
Anaemia	Blood and lymphatic system disorders	—
Arrhythmia	Cardiac disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Hiatus hernia	Gastrointestinal disorders	—
Chronic tonsillitis	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Sepsis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Head injury	Injury, poisoning and procedural complications	—
Spondylolisthesis	Musculoskeletal and connective tissue disorders	—
Epilepsy	Nervous system disorders	—
VIth nerve paralysis	Nervous system disorders	—
Menorrhagia	Reproductive system and breast disorders	—
Oligomenorrhoea	Reproductive system and breast disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Total
Nasopharyngitis	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Hypothyroidism	Endocrine disorders	—
Respiratory tract infection	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Acne	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—

Most-reported serious reactions: Syncope, Anaemia, Arrhythmia, Gastrooesophageal reflux disease, Hiatus hernia, Chronic tonsillitis, Nasopharyngitis, Pneumonia.

Data from ClinicalTrials.gov NCT01491854 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

One-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age.
Schwarz HP, Birkholz-Walerzak D, Szalecki M, Walczak M, et al · · 2014 · cited 12× · PMID 24676989 · DOI 10.1007/s13554-014-0014-4

Verify or expand the search:

Other trials of Bloodsampling

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01491854 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sandoz
Last refreshed: 14 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01491854.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01491854: SGA

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (16 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Bloodsampling

Other Sandoz trials

Verify against primary sources