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Dwarfism, Pituitary clinical trials

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NCT ID: NCT01775358 Completed - Clinical trials for Growth Hormone Deficiency

Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Start date: January 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.

NCT ID: NCT01718041 Completed - Clinical trials for Pediatric Growth Hormone Deficiency

Versartis Trial in Children to Assess Long-Acting Growth Hormone

VERTICAL
Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.

NCT ID: NCT01706783 Completed - Clinical trials for 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

Start date: October 12, 2012
Phase: Phase 1
Study type: Interventional

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 daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

NCT ID: NCT01616095 Completed - Clinical trials for Growth Hormone Deficiency

Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype

GHAT
Start date: April 2011
Phase:
Study type: Observational

This study is designed as a follow up study to that performed in 2005. In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was combined with in depth molecular and cellular biology analyses aimed at investigating the adipose tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD patients. Results published in (Ukropec et al., 2008) In this study identical endpoints will be investigated with the same methodology and within the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH therapy affects the - whole body insulin sensitivity - energy expenditure - body fat distribution - hepatic and skeletal muscle lipid content; as well as how it influences the adipose tissue - endocrine, - metabolic & - inflammatory phenotypes. The strength of the planned study lies in the extensive whole body and adipose tissue phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine the long-term effects of rhGH replacement therapy in GHD adults. Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of the study protocol as well as the stringency of the inclusion criteria. The clinical data obtained by methods of - integrated physiology would provide an excellent interpretation background for molecular-genetic studies at the tissue (adipose tissue) and cellular (adipocytes) level. Integration of the two could bring a new quality in the investigators understanding of metabolic derangements present in GHD, and will allow extending the investigators knowledge on the mechanisms of the long-term rhGH-therapy-induced improvement on body composition, metabolic health and the cardiovascular risk.

NCT ID: NCT01613573 Completed - Clinical trials for Growth Hormone Deficiency

Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

Phase 1
Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

NCT ID: NCT01605331 Completed - Clinical trials for Growth Hormone Deficiency

Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Start date: December 2009
Phase: Phase 4
Study type: Interventional

As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

NCT ID: NCT01604161 Completed - Turner Syndrome Clinical Trials

Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

NordiPAD
Start date: May 2005
Phase: N/A
Study type: Observational

This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.

NCT ID: NCT01580605 Completed - Clinical trials for Adult Growth Hormone Deficiency

French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

Start date: July 17, 2003
Phase:
Study type: Observational

This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

NCT ID: NCT01576861 Completed - Clinical trials for Chronic Heart Failure

Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

Start date: January 2007
Phase: Phase 2
Study type: Interventional

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.

NCT ID: NCT01563926 Completed - Turner Syndrome Clinical Trials

Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Start date: October 23, 2000
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.