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

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LG Life Sciences

Status and phase

Completed
Phase 2

Conditions

Establishing Dose of Sr-hGH in ISS Patients

Treatments

Drug: human growth hormone self-injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT02042170
LG-SHCL010

Details and patient eligibility

About

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).

Enrollment

46 patients

Sex

All

Ages

4 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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