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

• Sponsor: LG Life Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02042170
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 3
• Duration (Months): 12.9
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Establishing Dose of Sr-hGH in ISS Patients	Drug: human growth hormone self-injection	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in height velocity at Week 26, cm/year [Week 0-26]

Secondary Outcome Measures

1. Change from baseline in height velocity, cm/year [at Week 13]

2. Change from baseline in height, cm [at Week 13 and 26]

3. Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score) [at Week 13 and 26]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ho Sung Kim	Seoul		Korea, Republic of

Sponsors and Collaborators

• LG Life Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Life Sciences
• ClinicalTrials.gov Identifier: NCT02042170
• Other Study ID Numbers: LG-SHCL010
• First Posted: Jan 22, 2014
• Last Update Posted: Mar 24, 2016
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hormones

Study Results

No Results Posted as of Mar 24, 2016