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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorLG Chem

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

children with GHD, TS, CRF, SGA and ISS

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

6,000 Participants
are grouped into 1 trial group
Group A: growth hormone

Trial outcomes

Primary outcomes

1

Safety measure : adverse event

Time frame
up to 2 years after epiphyseal closure

Secondary outcomes

1

effectiveness measure : difference in target height and final height

Time frame
up to 2 years after epiphyseal closure
2

effectiveness : difference in height velocity between Baseline and every year

Time frame
up to 2 years after epiphyseal closure
3

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

Time frame
up to 2 years after epiphyseal closure

Other outcomes

Sponsors and contacts

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