Clinical trials: Born Small for Gestational Age
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 Disorder, Small for Gestational Age
French National Registry of Children Born Small for Gestational Age Treated With Somatropin
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin®…
- Trial name
- NCT01578135
- Testing
- somatropin
- Where
- France
- Volunteers
- 291 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
This non-interventional study for prospective follow up of a cohort of 220 subjects born small for gestational age (SGA) is planned for the purpose of finding out if normalisation of adult height is associated or not with…
- Trial name
- SGA (NCT01196156)
- Where
- 28 sites in Spain
- Volunteers
- 443 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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 Gestational Age (SGA)
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving…
- Trial name
- SGA OPTIMIS (NCT00249821)
- Testing
- Saizen®
- Volunteers
- 22 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Fetal Growth Retardation
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.
- Trial name
- NCT00174252
- Testing
- Genotonorm (Somatropin)
- Where
- 22 sites in France
- Volunteers
- 57 people
- Sponsor
- Pfizer
Children Born With Serious Intra-uterine Growth Retardation
Saizen in Intra-uterine Growth Retardation
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.
- Trial name
- NCT01400698
- Testing
- Saizen® A, Saizen® B, Observation only
- Volunteers
- 91 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
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
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 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
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- NCT01245374
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 103 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
Short Stature Children Born Small for Gestational Age (SGA)
Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature
The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided…
- Trial name
- NCT02375620
- Testing
- PEG-somatropin
- Where
- 9 sites in China
- Volunteers
- 96 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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.
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
- Trial name
- NCT00519844
- Testing
- somatropin
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Novo Nordisk A/S
Infant, Small for Gestational Age
Efficacy and Safety of DA-3002 in Short Children Borns SGA.
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
- Trial name
- SGA (NCT02770157)
- Testing
- DA-3002, Genotropin®
- Where
- South Korea
- Volunteers
- 75 people
- Sponsor
- Dong-A ST Co., Ltd.
Growth Disorders
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well.
- Trial name
- NCT00174408
- Testing
- Genotropin
- Volunteers
- 110 people
- Sponsor
- Pfizer
Growth Disorder
Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
- Trial name
- NCT00174421
- Testing
- Treatment with Genotropin in different dosages
- Volunteers
- 36 people
- Sponsor
- Pfizer
Small For Gestational Age (SGA)
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).
- Trial name
- GH-RAST (NCT01897753)
- Testing
- growth hormone
- Where
- 12 sites in Spain
- Volunteers
- 264 people
- Sponsor
- Pfizer