Clinical trials: SGA
Infant, Small for Gestational Age
SURF, Neurodevelopment, Growth Study in SGA Infants
The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of…
- Trial name
- NCT04360967
- Testing
- Standard Formula, Nutrient-enriched Formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Short Stature Children Born Small for Gestational Age (SGA)
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will…
- Trial name
- NCT07260500
- Testing
- PEG-rhGH Injection, hGH Injection
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Small for Gestational Age
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).
- Trial name
- NCT00537914
- Testing
- Omnitrope
- Where
- 31 sites in Belgium, Czechia and 5 more
- Volunteers
- 278 people
- Sponsor
- Sandoz
Small for Gestational Age
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH…
- Trial name
- NCT07841678
- Testing
- PEG-hGH Injection, hGH Injection
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Foetal Growth Problem, Small for Gestational Age
Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short…
- Trial name
- NCT01110928
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 227 people
- Sponsor
- Novo Nordisk A/S
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
- Trial name
- NCT00184717
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 98 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Safety and Efficacy of Long-term Somatropin Treatment in Children
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- GrowthWIN II (NCT01543867)
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 5,442 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
- Trial name
- SAIZEN in SGA (NCT01067352)
- Testing
- Recombinant human growth hormone (r-hGH)
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Foetal Growth Problem, Small for Gestational Age
Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
- Trial name
- NCT00557336
- Testing
- somatropin
- Where
- 37 sites in Spain
- Volunteers
- 160 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)
This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital…
- Trial name
- SEPAGE (NCT01082354)
- Testing
- recombinant somatropin
- Where
- 40 sites in France
- Volunteers
- 150 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Therapy, Infant, Small for Gestational Age
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
- Trial name
- SGA-POWER (NCT00625872)
- Testing
- Somatropin
- Where
- 10 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Pfizer
Small for Gestational Age
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in…
- Trial name
- NCT07309562
- Testing
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Where
- 49 sites in China
- Volunteers
- 141 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Infant, Small for Gestational Age
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass…
- Trial name
- NCT00396474
- Testing
- post GH treatment observational study
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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)
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and…
- Trial name
- NCT03972345
- Testing
- Norditropin® FlexPro®
- Where
- Germany
- Volunteers
- 750 people
- Sponsor
- Novo Nordisk A/S
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Small for Gestational Age
Long Term Use of Somatropin in Patients Small for Gestational Age
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00793325
- Testing
- Somatropin
- Volunteers
- 920 people
- Sponsor
- Pfizer
SGA, Turner Syndrome, Noonan Syndrome, ISS
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature.
- Trial name
- REAL 8 (NCT05330325)
- Testing
- Somapacitan, Norditropin®
- Where
- 199 sites in United States, Austria and 31 more
- Volunteers
- 412 people
- Sponsor
- Novo Nordisk A/S
Foetal Growth Problem, Small for Gestational Age
Efficacy on Height in SGA Children Treated With Growth Hormone
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.
- Trial name
- NCT00184756
- Testing
- somatropin
- Where
- 37 sites in Czechia, Finland and 6 more
- Volunteers
- 151 people
- Sponsor
- Novo Nordisk A/S
Short Children Born Small for Gestational Age (SGA)
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
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…
- Trial name
- SGA (NCT01491854)
- Testing
- Bloodsampling
- Where
- 23 sites in Czechia, Georgia and 4 more
- Volunteers
- 130 people
- Sponsor
- Sandoz