Clinical trials: ISS
Growth Hormone Deficiency, Idiopathic Short Stature
Genotropin Study Assessing Use of Injection Pen
Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months.
- Trial name
- NCT00965484
- Testing
- New Genotropin Pen
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- Pfizer
ISS- Idiopathic Short Stature
The Effect of Nutritional Formula Supplementation on Linear Growth of Growth Hormone (GH) Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy
The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of combined growth hormone (GH) treatment \&nutritional formula supplementation versus GH \& placebo on…
- Trial name
- NCT04962360
- Testing
- Nutritional supplementation standardized formula
- Where
- Israel
- Volunteers
- 64 people
- Sponsor
- Rabin Medical Center
HIV Infections
Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020)
A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by…
- Trial name
- T003EFUP2020 (NCT05680948)
- Where
- South Africa
- Volunteers
- 179 people
- Sponsor
- Istituto Superiore di Sanità
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.
Turner Syndrome, Idiopathic Short Stature
Study to Identify Markers of Insulin Resistance During Growth Hormone Treatment for Short Stature
Growth hormone treatment improves body fat distribution but also causes insulin resistance. Scientists have recently linked insulin resistance with special stores of fat in the muscles, which can be measured by magnetic resonance…
- Trial name
- NCT00121875
- Testing
- somatropin (rDNA)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Massachusetts General Hospital
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
NK Cells in Cord Blood Transplantation
This phase I trial studies the side effects and best way to give natural killer cells and donor umbilical cord blood transplant in treating patients with hematological malignancies.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission
- Trial name
- NCT01619761
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Fludarabine Phosphate
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
- 52 sites in United States, France and 5 more
- Volunteers
- 186 people
- Sponsor
- Ascendis Pharma 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
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end.
- Trial name
- ThrasherAI (NCT01248416)
- Testing
- Aromatase Inhibitor, Growth Hormone, Aromatase Inhibitor and Growth Hormone
- Where
- 4 sites in United States, Chile
- Volunteers
- 76 people
- Sponsor
- Nemours Children's Clinic
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
Wounds and Injuries
Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.
- Trial name
- NCT02175862
- Where
- Denmark
- Volunteers
- 1,791 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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.
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
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.
Idiopathic Short Stature, Self Image
Short Stature Related Distress
The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized…
- Trial name
- NCT01246219
- Testing
- GH treatment (Genotropin)
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Rabin Medical Center
Pituitary Dwarfism, Idiopathic Short Stature
Pharmacodynamics of CNP During Growth Hormone Treatment
It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable.
- Trial name
- NCT01504802
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Nemours Children's Clinic
Insulin-like Growth Factor-1 Deficiency
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary).
- Trial name
- NCT00572156
- Testing
- NutropinAq® (Somatropin [rDNA origin]), Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Ipsen
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 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.