Clinical trials: Bone Diseases, Endocrine
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring…
- Conditions
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
- Trial name
- NCT03186495
- Testing
- Somapacitan
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
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.
Primary Insulin-like Growth Factor-1 Deficiency
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.).
- Trial name
- NCT00747604
- Testing
- mecasermin [rDNA origin] injection
- Where
- United States
- Volunteers
- 1,378 people
- Sponsor
- Ipsen
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
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Trial name
- NCT01785849
- Testing
- Etelcalcetide
- Where
- 118 sites in United States, Australia and 13 more
- Volunteers
- 508 people
- Sponsor
- Amgen
Renal Osteodystrophy
12-month Study of AMG 073 in Renal Osteodystrophy
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium.
- Trial name
- NCT00527085
- Testing
- AMG 073
- Volunteers
- 45 people
- Sponsor
- Amgen
Dwarfism, Growth Hormone Deficiency
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood
This was a 48-week, open-label, prospective, multicentric, randomised, comparative with parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD subjects during the transition phase from…
- Trial name
- NCT01157793
- Testing
- r-hGH
- Volunteers
- 34 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different…
- Trial name
- NCT00184743
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 112 people
- Sponsor
- Novo Nordisk A/S
Secondary Hyperparathyroidism
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
- Trial name
- NCT02133404
- Testing
- ASP7991, Cinacalcet
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Achondroplasia
An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia
This is a Phase 2, open-label multi-center long-term extension study, with approximately 70 subjects, to evaluate the safety and efficacy of BMN111 in children with Achondroplasia until subjects reach near-adult final height.
- Trial name
- NCT03989947
- Testing
- Active BMN 111: Subcutaneous injection of recommended dose of BMN 111 based on weight-band dosing once daily.
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 73 people
- Sponsor
- BioMarin Pharmaceutical
Achondroplasia
A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.
- Trial name
- NCT03197766
- Testing
- BMN 111
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- BioMarin Pharmaceutical
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Systemic Lupus Erythematosus
WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)
The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE).
- Trial name
- NCT01616472
- Testing
- Cumulative corticosteroid exposure
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Pituitary Disorders, Adult Growth Hormone Deficiency
Treatment of Adults With Growth Hormone Deficiency
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental…
- Trial name
- NCT00596037
- Testing
- Growth hormone - LB03002
- Volunteers
- 136 people
- Sponsor
- LG Life Sciences
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA…
- Trial name
- NCT00184730
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 86 people
- Sponsor
- Novo Nordisk A/S
Acromegaly
Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).
- Trial name
- ACRO QLQ (NCT02396966)
- Where
- 18 sites in Poland
- Volunteers
- 152 people
- Sponsor
- Ipsen
Acromegaly
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL) therapy.
- Trial name
- NCT03967249
- Testing
- IONIS GHR-LRx, Somatostatin Receptor Ligand (SRL)
- Where
- 22 sites in United States, Hungary and 4 more
- Volunteers
- 39 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Adult Growth Hormone Deficiency
Metabolic Endocrinology and Growth Hormone in Adults
This is a multicentric, longitudinal, observational study with the prospective follow-up of Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six months in the first year and then annually.
- Trial name
- MEGHA FRANCE (NCT01080755)
- Volunteers
- 90 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency…
- Trial name
- NCT01060488
- Testing
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Type 2 Diabetes Mellitus
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic…
- Trial name
- SOTA-BONE (NCT03386344)
- Testing
- Sotagliflozin
- Where
- 53 sites in United States, Australia and 6 more
- Volunteers
- 376 people
- Sponsor
- Lexicon Pharmaceuticals