CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 458 enrolled
Drug / intervention
Blood samplingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01419249
NCT01419249Phase 4Completed
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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

Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 18, 2011·Updated Jan 16, 2014

In Brief

A Phase 4 clinical trial evaluating Blood sampling for Idiopathic Growth Hormone Deficiency and Turner Syndrome. Completed, enrolled 458 participants across 31 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Growth Hormone Deficiency, Turner Syndrome
CountriesArgentina, Canada, Czechia, France, Germany, Italy, Spain, Sweden, United Kingdom
CollaboratorsMerck Serono S.A., Geneva

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.9 years ago

Interventions

Blood samplingother

Subjects with pre-established diagnosis of IGHD and TS and were treated with r-hGH therapy for 1 year, will be observed in this retrospective cohort study wherein blood sampling will performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.