Clinical trials: ISS
Colorectal Neoplasms
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
The main objectives of this study are to establish a safe, tolerable and active dose of 1018 ISS administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer.
- Trial name
- NCT00403052
- Testing
- 1018 ISS immunostimulatory oligonucleotide
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Dynavax Technologies Corporation
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
Chronic Spontaneous Urticaria
A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines
The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine…
- Trial name
- BISCUIT (NCT05048342)
- Testing
- LOU064
- Where
- 13 sites in Japan
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals
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.
Ischemic Stroke
Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial
The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.
- Trial name
- ImpACT-P (NCT04014621)
- Testing
- SPG stimulation
- Where
- 4 sites in Georgia
- Volunteers
- 100 people
- Sponsor
- BrainsGate
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
Osteoporotic Fracture of Vertebra
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed.
- Trial name
- NCT04495439
- Testing
- Augmentation with the ISS Study System, Augmentation with PMMA
- Where
- Austria
- Volunteers
- 2 people
- Sponsor
- Nexilis AG
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
Lumbar Spinal Stenosis, Intermittent Claudication
Investigating Superion™ In Spinal Stenosis
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of…
- Trial name
- NCT00692276
- Testing
- Superion™ Interspinous Spacer, X-STOP® IPD® Device
- Where
- 32 sites in United States
- Volunteers
- 391 people
- Sponsor
- Boston Scientific Corporation
Huntington's Disease
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.
- Trial name
- NCT06585449
- Testing
- ALN-HTT02
- Where
- 19 sites in Canada, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- Alnylam Pharmaceuticals
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
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
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.
Multiple Myeloma
A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM.
- Trial name
- KarMMa-4 (NCT04196491)
- Testing
- bb2121, Fludarabine, Cyclophosphamide
- Where
- 22 sites in United States
- Volunteers
- 13 people
- Sponsor
- Celgene
Ischemic Stroke
THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)
Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2.
- Trial name
- ImpACT-24M (NCT03551093)
- Testing
- ISS SPG stimulation
- Where
- 4 sites in Georgia
- Volunteers
- 50 people
- Sponsor
- BrainsGate
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.