Long Term Follow up Study of Predictive Markers in GHD and TS Children - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00699855

Purpose

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).

Condition
Growth Hormon Deficiency Turner Syndrome in Pre-Pubertal Children

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Turner Syndrome

U.S. FDA Resources

Study Type:	Observational
Official Title:	Observational Long-Term Follow-up of the Phase IV Open-Label Trial of Predictive Markers in GHD and TS Pre-Pubertal Children Treated With Saizen

Further study details as provided by EMD Serono:

Primary Outcome Measures:

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). [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	260
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects initially enrolled in PREDICT (NCT 00256126) clinical study and continuing a growth hormone treatment.

Criteria

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

Exclusion Criteria:

Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699855

Contacts

Contact: Hervé Villemagne

herve.villemagne@merckserono.net

Locations

Switzerland
Local Medical Information	Recruiting
Zug, Switzerland
Contact: Local Medical Information 41-41-747-0812

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Clément Olivier, MD, LMCC

Merck Serono S.A., Geneva an affiliate of Merck KGaA, Darmstadt, Germany

More Information

No publications provided

Responsible Party:	Merck Serono S.A., Geneva an affiliate of Merck KGaA, Darmstadt, Germany ( Hervé Villemagne )
Study ID Numbers:	28614
Study First Received:	June 13, 2008
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00699855 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by EMD Serono:

Growth Hormon Deficiency and
Turner Syndrome in pre-pubertal children
Long term follow-up of predictive markers

Study placed in the following topic categories:

Gonadal Disorders
Genital Dwarfism
Chromosome Disorders
Endocrine System Diseases
Ovarian Dwarfism
Sex Differentiation Disorders
Monosomy X

Turner Syndrome
Urogenital Abnormalities
Genetic Diseases, Inborn
Endocrinopathy
Congenital Abnormalities
Gonadal Dysgenesis

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Chromosome Disorders
Endocrine System Diseases
Sex Differentiation Disorders
Turner Syndrome
Pathologic Processes

Urogenital Abnormalities
Genetic Diseases, Inborn
Syndrome
Sex Chromosome Disorders
Congenital Abnormalities
Gonadal Dysgenesis

ClinicalTrials.gov processed this record on May 07, 2009