Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

LG Chem6,000 enrolled

Overview

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).

Study Type

OBSERVATIONAL

Enrollment

6,000

Conditions

Growth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age Idiopathic Short Stature

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * short stature children aged 2 years or more * children with GHD,TS, CRF, SGA or ISS * written informed consent from the person, person's parent or legal guardian

Locations (1)

Outcomes

Primary Outcomes

Safety measure : adverse event

Time frame: up to 2 years after epiphyseal closure

Secondary Outcomes

effectiveness measure : difference in target height and final height

Time frame: up to 2 years after epiphyseal closure

effectiveness : difference in height velocity between Baseline and every year

Time frame: up to 2 years after epiphyseal closure

effectiveness measure : difference in height SDS for CA between baseline and every 6 months

Time frame: up to 2 years after epiphyseal closure

Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts