NCT03309891

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	GX-H9	subcutaneous injection (weekly or twice-monthly)
DRUG	Genotropin	subcutaneous injection (daily)

Timeline

• Start date: 2016-01-18
• Primary completion: 2017-10-27
• Completion: 2019-05-15
• First posted: 2017-10-16
• Last updated: 2020-04-20

Locations

1 site across 1 country: Ukraine