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

Phase 2CompletedNCT02042170

LG Life Sciences46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Establishing Dose of Sr-hGH in ISS Patients

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in height velocity at Week 26, cm/year

Time frame: Week 0-26

Secondary Outcomes

Change from baseline in height velocity, cm/year

Time frame: at Week 13

Change from baseline in height, cm

Time frame: at Week 13 and 26

Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)