CompletedPhase 4

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

Argentina, Canada458 participantsStarted 2011-09

Plain-language 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 deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change From Baseline in Height at Year 1

Timeframe: Baseline and Year 1

Change From Baseline in Height Standard Deviation Score (SDS) at Year 1

Timeframe: Baseline and Year 1

Height Velocity Standard Deviation Score (SDS) at Year 1

Timeframe: Year 1

Trial details

NCT IDNCT01419249

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2013-11-26

View on ClinicalTrials.gov More Idiopathic Growth Hormone Deficiency trials