NCT02042170

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

Completed Phase 2 Last updated 23 March 2016

What this trial tests

Phase 2 trial testing human growth hormone self-injection in Establishing Dose of Sr-hGH in ISS Patients in 46 participants. Completed in 1 March 2015.

Timeline

1 February 2014

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	LG Life Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	1 February 2014
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	1 location across South Korea

Drugs / interventions tested

• human growth hormone self-injection — full drug profile →

Conditions studied

• Establishing Dose of Sr-hGH in ISS Patients — all drugs for Establishing Dose of Sr-hGH in ISS Patients →

Sponsor

LG Life Sciences — full company profile →

Who can join

Adults 4 to 14, any sex, with Establishing Dose of Sr-hGH in ISS Patients. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in height velocity at Week 26, cm/year
  Time frame: Week 0-26

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study.
   Hwang JS, Lee HS, Lee KH, Yoo HW, et al · · 2018 · cited 16× · PMID 29925064 · DOI 10.1159/000489262