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Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Sponsor: Esteve Pharmaceuticals, S.A.
Summary
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2008-12-09
Completion Date
2027-12-31
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Increlex®
Increlex® (mecasermin \[rDNA origin\] injection), 10 mg/ml solution for injection, 40-120mcg/kg BID or 0,04 to 0,12 mg/kg BID, as prescribed by physician
Locations (58)
Children's Hospital of Orange County
Orange, California, United States
University of Miami Leonard M Miller
Miami, Florida, United States
University Of Miami Leonard M. Miller
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Children's Health Specialty Center West Plano
Plano, Texas, United States
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, Austria
Hôpital Amiens-Picardie
Amiens, France
Centre Hospitalier de Blois
Blois, France
Hôpital Jean Verdier
Bondy, France
Hôpital Femme Mère-Enfant
Bron, France
Hôpital Estaing
Clermont-Ferrand, France
Hôpital Timone Enfants
Marseille, France
Hôpital Arnaud de Villeneuve
Montpellier, France
GHR Mulhouse Sud-Alsace
Mulhouse, France
Pole medical Bel'Air
Mulhouse, France
CHU Lenval
Nice, France
Hôpital Necker Enfants Malades
Paris, France
Hôpital Kremlin Bicetre
Paris, France
Hôpital des Enfants
Toulouse, France
Hôpital de Cayenne
Cayenne, French Guiana
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, Germany
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, Germany
Universitätskliniken des Saarlandes Kinderklinik
Homburg, Germany
Klinikum der Otto von Guericke Universität
Magdeburg, Germany
Klinikum Oldenburg
Oldenburg, Germany
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona, Italy
Ospedale di Bolzano
Bolzano, Italy
Spedali Civili di Brescia
Brescia, Italy
Azienda ospedaliera universitaria Meyer
Florence, Italy
I.R.C.C.S. Giannina Gaslini
Genova, Italy
U.O. Pediatria e Neonatologia Ospedale di Macerata
Macerata, Italy
Azienda Ospedaliera Universitaria II
Naples, Italy
Azienda Ospedaliera-Universitaria di Parma
Parma, Italy
Azienda USL-IRCCS
Reggio Emilia, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Hôpital Pierre Zobda Quitman
Fort-de-France, Martinique
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, Poland
Szpital kliniczny im. Karola Jonschnera
Poznan, Poland
Kliniczny Szpital Wojewódzki
Rzeszów, Poland
Pomeranian Medical University
Szczecin, Poland
Hospital Univ Vall d'Hebrón
Barcelona, Spain
Hospital Parc Taulí de Sabadell
Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, Spain
Hospital Univ. de Cruces
Bilbao, Spain
Hospital Universitari Sant Joan de Reus
Reus, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Linköping University Hospital
Linköping, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
The Royal London Hospital
London, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom