Clinical trials: Gestational Age
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
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
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
SARS-CoV-2
AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
- Trial name
- TRUST (NCT05281601)
- Testing
- AZD7442
- Where
- 11 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Prospective Study on Patients Treated With Norditropin®
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic Disorder
- Trial name
- NCT00960128
- Testing
- somatropin
- Where
- 23 sites in Argentina, Belgium and 21 more
- Volunteers
- 21,249 people
- Sponsor
- Novo Nordisk A/S
Turner Syndrome, Short Stature Homeobox Gene Mutation
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
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates.
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Trial name
- NCT07221851
- Testing
- Lonapegsomatropin [SKYTROFA®], Somatropin Pen Injector
- Where
- 56 sites in United States, France and 5 more
- Volunteers
- 186 people
- Sponsor
- Ascendis Pharma A/S
Healthy Infants
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to…
- Trial name
- NCT01896739
- Testing
- Eutravac
- Where
- 7 sites in South Korea
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
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)
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Small for Gestational Age (SGA)
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
- Trial name
- NCT01897766
- Testing
- Somatropin
- Volunteers
- 482 people
- Sponsor
- Pfizer
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
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
Congenital Cytomegalovirus Infection
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection.
- Trial name
- PreCyssion (NCT05170269)
- Testing
- BT097
- Where
- 5 sites in Germany
- Volunteers
- 48 people
- Sponsor
- Biotest
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.
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
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
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