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

Growth Hormon Deficiency Clinical Trial

— PREDICT LT FUP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699855
• Other study ID #: 28614
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: February 17, 2014
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Growth Hormon Deficiency
• Primary Ovarian Insufficiency
• Turner Syndrome
• Turner Syndrome in Pre-pubertal Children

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

References & Publications (1)

Clayton P, Chatelain P, Tatò L, Yoo HW, Ambler GR, Belgorosky A, Quinteiro S, Deal C, Stevens A, Raelson J, Croteau P, Destenaves B, Olivier C. A pharmacogenomic approach to the treatment of children with GH deficiency or Turner syndrome. Eur J Endocrinol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Yearly	No
Secondary	When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.		Yearly	No