Clinical trials: ISS
Establishing Dose of Sr-hGH in ISS Patients
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS).
- Trial name
- NCT02042170
- Testing
- human growth hormone self-injection
- Where
- South Korea
- Volunteers
- 46 people
- Sponsor
- LG Life Sciences
Hepatitis B
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old.
- Trial name
- NCT00435812
- Testing
- Engerix-B
- Where
- 18 sites in Canada, Germany
- Volunteers
- 2,428 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Growth Hormone Deficiency, Turner Syndrome
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal…
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Trial name
- LGS (NCT01604395)
- Where
- South Korea
- Volunteers
- 6,000 people
- Sponsor
- LG Chem
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
Growth Disorder
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were…
- Trial name
- NCT00191074
- Testing
- somatropin, rDNA origin, for injection
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Eli Lilly and Company
Idiopathic Short Stature
A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and…
- Trial name
- NCT07450053
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Dwarfism
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.
- Trial name
- NCT03635580
- Testing
- Negative control
- Where
- 9 sites in China
- Volunteers
- 480 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Idiopathic Short Stature
Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of…
- Trial name
- NCT00396097
- Testing
- Genotropin
- Where
- 43 sites in United States
- Volunteers
- 316 people
- Sponsor
- Pfizer
Dwarfism
A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature
This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children with idiopathic short stature (ISS), evaluate its safety and efficacy, and provide scientific and…
- Trial name
- NCT03221088
- Testing
- Jintrolong® low dose group, Jintrolong® high dose group
- Where
- 7 sites in China
- Volunteers
- 360 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
Idiopathic Short Stature
A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
This is an open-label, multi-center, randomized, two-arm parallel, no-treatment group controlled (only for the first 6 months), Phase 3 study in children with ISS.
- Trial name
- NCT01746862
- Testing
- Saizen®
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Disorder, Idiopathic Short Stature
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
- Trial name
- NCT01778023
- Testing
- somatropin
- Where
- 8 sites in South Korea
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
Idiopathic Short Stature
Epidemiology Study on Insulin-like Growth Factor-1 in Children With Idiopathic Short Stature (EPIGROW Study)
The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not…
- Trial name
- EPIGROW (NCT00710307)
- Testing
- Blood sampling, Genetic analysis
- Where
- France
- Volunteers
- 275 people
- Sponsor
- Ipsen
Idiopathic Short Stature
A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature
The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children…
- Trial name
- NCT06382155
- Testing
- Vosoritide Injection, Human Growth Hormone
- Where
- 47 sites in United States, Australia and 4 more
- Volunteers
- 100 people
- Sponsor
- BioMarin Pharmaceutical
Idiopathic Short Stature, Small for Gestational Age
A Trial of YPEG-rhGH in Children With Short Stature
To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for…
- Conditions
- Idiopathic Short Stature, Small for Gestational Age, Turner Syndrome
- Trial name
- NCT05838885
- Testing
- YPEG-rhGH, rhGH
- Where
- 19 sites in China
- Volunteers
- 78 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
Idiopathic Short Stature (ISS)
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric…
- Trial name
- NCT07815626
- Testing
- Human Growth Hormone (hGH)
- Where
- 34 sites in China
- Volunteers
- 240 people
- Sponsor
- Zhongshan Sansure Hygene Biomedicine Co., Ltd.
Idiopathic Short Stature
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
- Trial name
- NCT01786902
- Testing
- DA-3002
- Volunteers
- 70 people
- Sponsor
- Dong-A ST Co., Ltd.
Dwarfism
A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature
After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with…
- Trial name
- NCT03255694
- Testing
- PEG-somatropin
- Where
- 12 sites in China
- Volunteers
- 360 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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