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).
Start Date
12/9/2008
Completion Date
12/31/2027
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.
Detailed Description
This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe Primary IGF-1 Deficiency and secondly to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively. The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA
Eligibility Criteria
Age Range: 2 years to 18 years
Interventions
Increlex®
Conditions
Locations
Children's Hospital of Orange County
Orange, California 92868
United States
University of Miami Leonard M Miller
Miami, Florida 33136
United States
University Of Miami Leonard M. Miller
Miami, Florida 33136
United States
D&H National Research Centers
Miami, Florida 33155
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Children's Health Specialty Center West Plano
Plano, Texas 75093
United States
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, A-4840
Austria
Hôpital Amiens-Picardie
Amiens, 80080
France
Centre Hospitalier de Blois
Blois, 41000
France
Hôpital Jean Verdier
Bondy, 93140
France
Hôpital Femme Mère-Enfant
Bron, 69500
France
Hôpital Estaing
Clermont-Ferrand, 63100
France
Hôpital Timone Enfants
Marseille, 13005
France
Hôpital Arnaud de Villeneuve
Montpellier, 34090
France
GHR Mulhouse Sud-Alsace
Mulhouse,
France
Pole medical Bel'Air
Mulhouse,
France
CHU Lenval
Nice, 06200
France
Hôpital Necker Enfants Malades
Paris, 75015
France
Hôpital Kremlin Bicetre
Paris, 97270
France
Hôpital des Enfants
Toulouse, 31300
France
Hôpital de Cayenne
Cayenne, 97306
French Guiana
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, 91054
Germany
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, 69120
Germany
Universitätskliniken des Saarlandes Kinderklinik
Homburg, 66424
Germany
Klinikum der Otto von Guericke Universität
Magdeburg, 39120
Germany
Klinikum Oldenburg
Oldenburg, 26133
Germany
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona,
Italy
Ospedale di Bolzano
Bolzano, 39100
Italy
Spedali Civili di Brescia
Brescia, 25100
Italy
Azienda ospedaliera universitaria Meyer
Florence, 50139
Italy
I.R.C.C.S. Giannina Gaslini
Genova, 16147
Italy
Azienda Ospedaliera Universitaria II
Naples, 80138
Italy
Azienda Ospedaliera-Universitaria di Parma
Parma,
Italy
U.O. Pediatria e Neonatologia Ospedale di Macerata
Province of Macerata,
Italy
Azienda USL-IRCCS
Reggio Emilia,
Italy
Ospedale Pediatrico Bambino Gesù
Roma, 00165
Italy
Hôpital Pierre Zobda Quitman
Fort-de-France, 97200
Martinique
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, 15-274
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-294
Poland
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, 20-093
Poland
Szpital kliniczny im. Karola Jonschnera
Poznan, 60-572
Poland
Kliniczny Szpital Wojewódzki
Rzeszów, 35-301
Poland
Pomeranian Medical University
Szczecin,
Poland
Hospital Univ Vall d'Hebrón
Barcelona, 08035
Spain
Hospital Parc Taulí de Sabadell
Barcelona, 08208
Spain
Hospital Sant Joan de Déu
Barcelona, 08950
Spain
Hospital Univ. de Cruces
Bilbao, 48903
Spain
Hospital Universitari Sant Joan de Reus
Reus, 43204
Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Spain
Linköping University Hospital
Linköping, 57850
Sweden
Karolinska Universitetssjukhuset
Stockholm, 17176
Sweden
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BA
United Kingdom
Birmingham Children's Hospital
Birmingham, B4 6NH
United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX
United Kingdom
The Royal London Hospital
London, E1 1FR
United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH
United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 0JH
United Kingdom