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Dwarfism, Pituitary clinical trials

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NCT ID: NCT03344458 Completed - Clinical trials for 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

enliGHten
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

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. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

NCT ID: NCT03309891 Completed - Clinical trials for Growth Hormone Deficiency

Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency

Start date: January 18, 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, active controlled, Phase 2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and semi-monthly doses of GX-H9 in the treatment of Paediatric Growth Hormone Deficiency (PGHD) as compared to the standard of care daily rhGH treatment.

NCT ID: NCT03305016 Completed - Clinical trials for Endocrine System Diseases

A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

Start date: November 13, 2017
Phase: Phase 3
Study type: Interventional

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. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Australia, and New Zealand.

NCT ID: NCT03223025 Completed - Clinical trials for Idiopathic Growth Hormone Deficiency

Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency

Start date: March 9, 2016
Phase: Phase 3
Study type: Interventional

This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either CinnaTropin® or Novo Nordisk growth hormone product in 30 children with Idiopathic Growth Hormone Deficiency. Patients were randomized to receive one of the products for three months. After that, each patient crossed over to the other arm to receive the other product for another three months. The primary objective of this study was to compare the efficacy of CinnaGen growth hormone (GH) with Nordilet. The secondary objectives of this study were further comparison and evaluation of efficacy along with safety between CinnaTropin® and Nordilet®.

NCT ID: NCT03212131 Completed - Clinical trials for Adult Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

Start date: August 16, 2017
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics). In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.

NCT ID: NCT03186495 Completed - Clinical trials for 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

Start date: June 20, 2017
Phase: Phase 1
Study type: Interventional

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 haemodialysis treatment) compared to subjects with normal renal function

NCT ID: NCT03139903 Completed - Seckel Syndrome Clinical Trials

The Primordial Dwarfisms: Diagnosis, Identification of the Molecular Basis of Seckel Syndrome and Microcephalic Osteodysplastic Primordial Dwarfism Type II

NANPIM
Start date: July 28, 2010
Phase: N/A
Study type: Observational

The purpose of this study si to define morphological and epidemiological parameters and identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic osteodysplastic primordial dwarfism type II (MOPDII).

NCT ID: NCT03075644 Completed - Clinical trials for 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

Start date: March 3, 2017
Phase: Phase 3
Study type: Interventional

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 adults with growth hormone deficiency.

NCT ID: NCT03018886 Completed - Clinical trials for Growth Hormone Deficiency

Diagnosing Adult Growth Hormone Deficiency

Start date: May 2001
Phase: N/A
Study type: Interventional

The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test

NCT ID: NCT03015909 Completed - Clinical trials for Chronic Renal Failure

Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.

Start date: August 11, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.