Status:
COMPLETED
Long Term Follow up Study of Predictive Markers in GHD and TS Children
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Growth Hormon Deficiency
Turner Syndrome in Pre-pubertal Children
Eligibility:
All Genders
Brief 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 Growt...
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 ...
Eligibility Criteria
Inclusion
- 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
- Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00699855
Start Date
September 1 2008
End Date
August 1 2012
Last Update
February 19 2014
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