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Dwarfism, Pituitary clinical trials

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NCT ID: NCT02229851 Completed - Clinical trials for Adult Growth Hormone Deficiency

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

REAL 1
Start date: October 31, 2014
Phase: Phase 3
Study type: Interventional

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

NCT ID: NCT02218710 Not yet recruiting - Clinical trials for Adult Onset Growth Hormone Deficiency

Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography

Start date: September 2014
Phase: N/A
Study type: Observational

The aim of the study is to assess bone geometry, bone compartment specific volumetric densities and micro-architecture as well as to evaluate non-invasive estimates of bone strength in patients with adult onset growth hormone deficiency.

NCT ID: NCT02173821 Completed - Clinical trials for Idiopathic Growth Hormone Deficiency

A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency

Start date: October 2014
Phase: Phase 3
Study type: Interventional

This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.

NCT ID: NCT02092779 Completed - Obesity Clinical Trials

Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study

Start date: March 2007
Phase: N/A
Study type: Observational

Obesity is a disease not always attributable to nutritional imbalance, frequently associated with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to explore pituitary morphology and its association with pituitary function and metabolic phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease in a cross-sectional .

NCT ID: NCT02068521 Terminated - Clinical trials for Pediatric Growth Hormone Deficiency

Versartis Long-Term Safety Study of Somavaratan

VISTA
Start date: March 3, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration. Patients will be monitored for safety throughout their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs, clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan), PK/PD assessments, and immunogenicity assessments. Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug dictionary.

NCT ID: NCT02018172 Terminated - Clinical trials for Growth Hormone Deficiency

Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device

ZOMAXEPT
Start date: July 2014
Phase: N/A
Study type: Observational

The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.

NCT ID: NCT02005198 Completed - Clinical trials for Adult Growth Hormone Deficiency

Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

Start date: March 2014
Phase: N/A
Study type: Observational

This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.

NCT ID: NCT01973244 Completed - Clinical trials for Growth Hormone Disorder

A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Start date: December 16, 2013
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

NCT ID: NCT01947907 Completed - Clinical trials for Growth Hormone Deficiency (GHD)

Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Start date: July 2013
Phase: Phase 2
Study type: Interventional

A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.

NCT ID: NCT01947894 Completed - Clinical trials for Growth Hormone Deficiency

A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients

Start date: November 20, 2013
Phase:
Study type: Observational

The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment. This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.