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

Phase 2

Completed

• Conditions: Establishing Dose of Sr-hGH in ISS Patients
• Interventions: Drug: human growth hormone self-injection

• Registration Number: NCT02042170
• Lead Sponsor: LG Life Sciences

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Study Start: 2014-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-09
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sr-hGH 0.5 mg/kg/wk	human growth hormone self-injection	Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself.
Sr-hGH 0.7 mg/kg/wk	human growth hormone self-injection	Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself.
Daily hGH 0.37 mg/kg/wk	human growth hormone self-injection	Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself.

Primary Outcome Measures

Name	Time	Method
Change from baseline in height velocity at Week 26, cm/year	Week 0-26

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ho Sung Kim; 🇰🇷 Seoul, Korea, Republic of