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

PHASE4CompletedINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Idiopathic Growth Hormone DeficiencyTurner Syndrome
Interventions
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.

Trial Locations (31)

Unknown

Hospital de Niños Ricardo Gutiérrez, Buenos Aires

Hospital de Pediatria Garrahan, Buenos Aires

Hospital de Niños de la Santisima Trinidad, Córdoba

University of Calgary - Alberta Children's Hospital, Calgary

CHU Sainte Justine Montréal, Montreal

Centre Hospitalier Universitaire de Sherbrooke - Fleurimont, Sherbrooke

British Columbia Children's Hospital, Vancouver

Fakultní nemocnice Brno, Brno

University Hospital Hradec Kralove, Hradec Králové

Faculty Hospital, Olomouc

University Hospital Praha Motol, Prague

Centre d'Endocrinologie Pédiatrique, Bordeaux

CHU Bordeaux - Hopital pédiatrique Pellegrin, Bordeaux

Hôpital Femme-Mère-Enfant, Bron

University of Cologne Children's Hospital, Cologne

University Children's Hospital, München

University of Bari Aldo Moro, Bari

Ospedale Microcitemico di Cagliari, Cagliari

Centro di Endocrinologia e Diabetologia Pediatrica, Catania

Istituto Giannina Gaslini - Clinica Pediatrica, Genova

Hospital 12 de Octubre, Madrid

Hospital Infantil Universitario Niño Jesús, Madrid

Hospital Universitario Gregorio Maran, Madrid

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

Hospital Miguel Servet, Zaragoza

Queen Silvia Children's Hospital, Gothenburg

Faculty of Health Sciences, Linkping University, Linköping

Karolinska University Hospital Campus Solna, Stockholm

Birmingham Children's Hospital, Birmingham

Royal Manchester Children's Hospital, Manchester

Sheffield Children's Hospital, Sheffield

All Listed Sponsors
collaborator

Merck Serono S.A., Geneva

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

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 | Biotech Hunter | Biotech Hunter