Clinical trials: Bone Diseases, Endocrine
Growth Hormone Disorder, Adult Growth Hormone Deficiency
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once…
- Trial name
- NCT01706783
- Testing
- somapacitan, Norditropin NordiFlex®
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 35 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
Growth Hormone Insensitivity Syndrome (GHIS), Laron Syndrome
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS.
- Trial name
- NCT00368173
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 15 sites in United States, Argentina and 12 more
- Sponsor
- Insmed Incorporated
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
Adult Growth Hormone Deficiency
A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth…
- Trial name
- NCT01247675
- Testing
- ACP-001 (TransCon hGH), Omnitrope
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 37 people
- Sponsor
- Ascendis Pharma A/S
Acromegaly, Pituitary Gigantism
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism.
- Trial name
- NCT01673646
- Testing
- Pasireotide LAR
- Where
- 27 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Achondroplasia
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants < 3 years old with ACH.
- Trial name
- NCT07169279
- Testing
- Infigratinib is provided as a single dose of minitablets for oral administration, Infigratinib is provided as sprinkle capsules for daily oral administration
- Where
- 12 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Safety and Efficacy of Long-term Somatropin Treatment in Adults
This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).
- Trial name
- NordiWIN (NCT01543880)
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 752 people
- Sponsor
- Novo Nordisk A/S
Cockayne Syndrome
Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome
This study is to compare the exposure of orally administered Prodarsan to the intravenous dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients.
- Trial name
- NCT01142154
- Testing
- Prodarsan
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- DNage B.V.
Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM)
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5.
- Conditions
- Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03174522
- Testing
- REX-001
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 49 people
- Sponsor
- Ixaka Ltd
Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children
GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Trial name
- NCT07553351
- Testing
- GB06, Norditropin®FlexProTM
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Kexing Biopharm Co., Ltd.
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
Growth Hormone Deficiency
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.
- Trial name
- NCT01731028
- Testing
- Somatropin
- Sponsor
- Ferring Pharmaceuticals
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies
This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Glioblastoma Multiforme, Melanoma
- Trial name
- NCT02498665
- Testing
- DSP-7888 Dosing Emulsion
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Sumitomo Pharma America, Inc.
Growth Hormone Deficiency
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
- Trial name
- IGHD (NCT00630487)
- Testing
- Somatropin
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Pfizer
Hyperparathyroidism, Secondary
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.
- Trial name
- NCT01788046
- Testing
- Etelcalcetide
- Where
- 106 sites in United States, Australia and 13 more
- Volunteers
- 515 people
- Sponsor
- Amgen
Growth Hormone Deficiency
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers.
- Trial name
- NCT02418767
- Testing
- MOD-4023
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Growth Hormone Deficiency
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early…
- Trial name
- NCT00191165
- Testing
- Somatropin
- Where
- 10 sites in Italy
- Volunteers
- 27 people
- Sponsor
- Eli Lilly and Company
Acromegaly
Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the…
- Trial name
- ACROSCREEN (NCT02020967)
- Testing
- Non-interventional cross-sectional survey
- Where
- 2 sites in Russia
- Volunteers
- 367 people
- Sponsor
- Ipsen
Acromegaly, GEP-NET
A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning…
- Trial name
- OXTEND-01 (NCT05364944)
- Testing
- Debio 4126, Sandostatin LAR, Somatuline ATG
- Where
- 14 sites in Denmark, France and 6 more
- Volunteers
- 19 people
- Sponsor
- Debiopharm International SA