NCT01419249

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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 visit. During the visit, subjects who give consent to participate in the trial will undergo blood sampling for genetic markers testing and retrospective data will be collected relative to the first year of the subject's r-hGH treatment. The r-hGH treatment followed by the subject is indicated the pediatric population, therefore most of the subjects included into the trial will be below 18 years old. This study is a non-investigational medicinal product (IMP) trial therefore no drug product data is provided.

Conditions

• Idiopathic Growth Hormone Deficiency
• Turner Syndrome

Interventions

Type	Name	Description
OTHER	Blood sampling	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-08-18
• Last updated: 2014-01-16
• Results posted: 2014-01-16

Locations

31 sites across 9 countries: Argentina, Canada, Czechia, France, Germany, Italy, Spain, Sweden, United Kingdom