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

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).

Study Overview

• Status: Completed
• Conditions: Establishing Dose of Sr-hGH in ISS Patients
• Intervention / Treatment: Drug: human growth hormone self-injection

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ho Sung Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Criteria

• are older than or equal to age of 4
• are pre-pubertal (Tanner's stage I)
• are younger than bone age of 9 in female; of 11 in male
• have less than 3 years of a difference in bone and chronological age
• have confirmed idiopathic short stature

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sr-hGH 0.5 mg/kg/wk; Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself.	Drug: human growth hormone self-injection
Experimental: Sr-hGH 0.7 mg/kg/wk; Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself.	Drug: human growth hormone self-injection
Active Comparator: Daily hGH 0.37 mg/kg/wk; Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself.	Drug: human growth hormone self-injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in height velocity at Week 26, cm/year	Week 0-26

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in height velocity, cm/year	at Week 13
Change from baseline in height, cm	at Week 13 and 26
Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)	at Week 13 and 26

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: LG-SHCL010