Home
Clinical Trials
Long Term Follow up Study of ...

Long Term Follow up Study of Predictive Markers in GHD and TS Children

Last Updated: 2014-02-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®

NCT00256126

Growth Hormone Deficiency Turner Syndrome

COMPLETED PHASE4

Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®

NCT01187550

Dwarfism, Pituitary

COMPLETED PHASE4

Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years

NCT01066052

Turner's Syndrome

COMPLETED PHASE4

A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood

NCT01157793

Dwarfism Growth Hormone Deficiency

COMPLETED PHASE4

Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

NCT00249821

Small Gestational Age (SGA)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment).

Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data.

When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.

This data will be collected yearly during the normal follow up visits during 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Hormon Deficiency Turner Syndrome in Pre-pubertal Children

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have completed the PREDICT study (NCT 00256126)
* Followed up at least 1 year when still under treatment after completion of PREDICT Trial
* Parent's or guardian's written consent given before any data collection