Clinical Trials Logo
  1. Home
  2. Growth Hormone Deficiency
  3. NCT03309891

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

Growth Hormone Deficiency Clinical Trial

Official title:
A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency

Clinical Trial Summary

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.

Clinical Trial Description

GX-H9 is a new hGH product fused to hybrid Fc in studies as a once-a-week and every other week dosing regimen designed to overcome the inconvenience of daily rhGH injections and is under the studies designed to determine if the safety profile is comparable to currently approved daily rhGH products. Obviating the need for daily injections may increase compliance and therefore efficacy, which would be of great benefit to both paediatric and adult patients with GHD and other disorders with associated growth impairment and need for hGH substitution. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03309891
Study type Interventional
Source Genexine, Inc.
Contact
Status Completed
Phase Phase 2
Start date January 18, 2016
Completion date May 15, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02243852 - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) N/A
Completed NCT01440686 - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Phase 1
Completed NCT00990340 - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method Phase 4
Completed NCT00149708 - Consequence of Lifetime Isolated Growth Hormone Deficiency N/A
Completed NCT00235599 - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children. N/A
Completed NCT00459940 - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients N/A
Completed NCT01157793 - 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 Phase 4
Completed NCT00004365 - Study of Pituitary Size and Function in Familial Dwarfism of Sindh N/A
Recruiting NCT00227253 - Chromosome 18 Clinical Research Center
Recruiting NCT04121780 - Growth Hormone Replacement Therapy for Retried Professional Football Players Phase 2
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT01090778 - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I) Phase 2
Completed NCT01062529 - Peripheral Metabolic Effects of Somatostatin N/A
Completed NCT00965484 - Genotropin Study Assessing Use of Injection Pen Phase 3
Completed NCT00616278 - National Cooperative Growth Study in CKD N/A
Completed NCT02693522 - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency Phase 3
Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
Terminated NCT01243892 - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device N/A
Withdrawn NCT00638287 - Inter-Assay Growth Hormone and IGF-I Variability N/A
Completed NCT00929799 - Growth Hormone and Glucose Metabolism Phase 4