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OpenTrials
Completed

NCT Number: NCT02042170

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

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).

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Key information

Conditions

Establishing Dose of Sr-hGH in ISS Patients

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ho Sung Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human growth hormone self-injection

Drug

Primary outcomes

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

    Time frame: Week 0-26

Secondary outcomes

  1. Change from baseline in height velocity, cm/year

    Time frame: at Week 13

  2. Change from baseline in height, cm

    Time frame: at Week 13 and 26

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

    Time frame: at Week 13 and 26

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2014
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.