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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Establishing Dose of Sr-hGH in ISS Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sr-hGH 0.5 mg/kg/wk

Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself.

Group Type EXPERIMENTAL

human growth hormone self-injection

Intervention Type DRUG

Sr-hGH 0.7 mg/kg/wk

Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself.

Group Type EXPERIMENTAL

human growth hormone self-injection

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

human growth hormone self-injection

Intervention Type DRUG

Interventions

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human growth hormone self-injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No