Status:
COMPLETED
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A., Geneva
Conditions:
Idiopathic Growth Hormone Deficiency
Turner Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone def...
Detailed Description
This study is an open-label, interventional, retrospective, multicenter, international study, single-arm, non-randomized, and non-controlled study. The subject's trial participation includes a single ...
Eligibility Criteria
Inclusion
- Pre-established diagnosis of IGHD or TS based on classical criteria with at least 1 year of r-hGH therapy and with Tanner stage 1 at treatment start
- Retrospective availability of a complete set of clinical, auxological and biological parameters necessary for building the predictive model
- Other protocol defined inclusion criteria could apply
Exclusion
- Acquired growth hormone deficiency (GHD)
- Any drug or disease that could affect growth during the first year of r-hGH treatment
- Other protocol defined exclusion criteria could apply
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT01419249
Start Date
September 1 2011
End Date
October 1 2012
Last Update
January 16 2014
Active Locations (31)
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1
Hospital de Niños Ricardo Gutiérrez
Buenos Aires, Argentina
2
Hospital de Pediatria Garrahan
Buenos Aires, Argentina
3
Hospital de Niños de la Santisima Trinidad
Córdoba, Argentina
4
University of Calgary - Alberta Children's Hospital
Calgary, Canada