Clinical trials: Development, Human
Adult Growth Hormone Deficiency, Growth Hormone Disorder
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered…
- Trial name
- REAL 2 (NCT02382939)
- Testing
- somapacitan, somatropin
- Where
- 28 sites in Denmark, France and 4 more
- Volunteers
- 92 people
- Sponsor
- Novo Nordisk A/S
Skin Care
To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.
- Trial name
- NCT04007159
- Testing
- Serum, Lotion, Cream
- Where
- Brazil
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Adult Growth Hormone Deficiency
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD), who are growth hormone (GH) treatment-naïve…
- Trial name
- NCT01806298
- Testing
- Saizen® solution for injection (referred as Saizen®)
- Where
- 19 sites in Australia, Germany and 2 more
- Volunteers
- 78 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
HIV Infections
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial.
- Trial name
- DOMINO (NCT04493216)
- Testing
- GSK3640254, ABC/3TC, FTC/TAF
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 161 people
- Sponsor
- ViiV Healthcare
Growth Disorders
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and…
- Trial name
- NCT00330668
- Testing
- rh IGF-1 (mecasermin)
- Where
- France
- Volunteers
- 114 people
- Sponsor
- Ipsen
Hepatitis B
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
- Trial name
- NCT01777295
- Testing
- Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B
- Where
- Belgium
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alveolar Ridge Preservation, Dental Implants
Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation…
- Trial name
- NCT03215667
- Testing
- easy-graft CLASSIC (beta-Tricalcium Phosphate)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sunstar Americas
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Disorder, Adult Growth Hormone Deficiency
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese…
- Trial name
- NCT03075644
- Testing
- somapacitan, Norditropin
- Where
- 12 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Deficiency
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®.
- Trial name
- T-jet® (NCT00990340)
- Testing
- T-jet® containing TevTropin®, TevTropin® needle-syringe injection method
- Volunteers
- 52 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Autism Spectrum Disorder
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.
- Trial name
- NCT03507569
- Testing
- RO7017773, [11C] Ro15-4513
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Infertility, Ovarian Stimulation
A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies
In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the uterine cavity has become a well established treatment for female infertility attributable to damaged fallopian tubes, endometriosis or…
- Trial name
- NCT01121991
- Testing
- Recombinant Human-Luteinizing Hormone (Luveris)
- Volunteers
- 55 people
- Sponsor
- EMD Serono
Metastatic Breast Cancer
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer.
- Trial name
- NCT02980341
- Testing
- Patritumab Deruxtecan
- Where
- 26 sites in United States, Japan
- Volunteers
- 182 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- enliGHten (NCT03344458)
- Testing
- TransCon hGH
- Where
- 42 sites in United States, Armenia and 9 more
- Volunteers
- 298 people
- Sponsor
- Ascendis Pharma A/S
Growth Disorders
Long-Acting Growth Hormone in Children Compared to Daily rhGH
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.
- Trial name
- VELOCITY (NCT02339090)
- Testing
- Somavaratan, rhGH
- Volunteers
- 138 people
- Sponsor
- Versartis Inc.
Growth Hormone Deficiency (GHD)
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
- Trial name
- NCT01237340
- Testing
- Saizen®
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- EMD Serono
Infertility
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing…
- Trial name
- FASHION (NCT02449889)
- Testing
- highly purified human chorionic gonadotropin, recombinant human chorionic gonadotropin
- Where
- Brazil
- Volunteers
- 176 people
- Sponsor
- Ferring Pharmaceuticals