NCT02042170

Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients

A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label. 45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week. Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week. Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).

Conditions

• Establishing Dose of Sr-hGH in ISS Patients

Interventions

Type	Name	Description
DRUG	human growth hormone self-injection

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-01-22
• Last updated: 2016-03-24

Locations

1 site across 1 country: South Korea