Phase
Condition
N/ATreatment
Increlex®
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For US : patients starting or planning to start or currently receiving treatmentwith Increlex® therapy for severe primary IGF-1 deficiency as defined by the USIncrelex® prescribing information or for growth hormone (GH) gene deletion who havedeveloped neutralizing antibodies to GH.For EU : patients starting or planning tostart or currently receiving treatment with Increlex® therapy according to thelocally approved product information.
Parents or legally authorized representatives if applicable must give signedinformed consent before any registry-related activities are conducted. Assent fromthe subject should also be obtained as appropriate
Exclusion
Exclusion Criteria:
Subject currently participating in an Increlex® clinical trial
Subject currently participating in any clinical trial for growth retardation
Patient with any contraindication to Increlex® or any condition subject to specialwarning as per the locally approved label
For US patients, these include patients with hypersensitivity to the activesubstance or any of the excipients, patients with active or suspected neoplasia andpatients with closed epiphyses.
For EU patients: these include patients with hypersensitivity to the activesubstance or any of the excipients, patients with active or suspected neoplasia orany condition or medical history which increases the risk of benign or malignantneoplasia and patients with closed epiphyses
Study Design
Study Description
Connect with a study center
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, A-4840
AustriaActive - Recruiting
Hôpital Amiens-Picardie
Amiens, 80080
FranceTerminated
Centre Hospitalier de Blois
Blois, 41000
FranceActive - Recruiting
Hôpital Jean Verdier
Bondy, 93140
FranceActive - Recruiting
Hôpital Femme Mère-Enfant
Bron, 69500
FranceActive - Recruiting
Hôpital Estaing
Clermont-Ferrand, 63100
FranceActive - Recruiting
Hôpital Timone Enfants
Marseille, 13005
FranceActive - Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34090
FranceActive - Recruiting
GHR Mulhouse Sud-Alsace
Mulhouse,
FranceTerminated
Pole medical Bel'Air
Mulhouse,
FranceActive - Recruiting
CHU Lenval
Nice, 06200
FranceSite Not Available
Hôpital Kremlin Bicetre
Paris, 97270
FranceActive - Recruiting
Hôpital Necker Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital des Enfants
Toulouse, 31300
FranceActive - Recruiting
Hôpital de Cayenne
Cayenne, 97306
French GuianaSite Not Available
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, 91054
GermanyActive - Recruiting
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, 69120
GermanyActive - Recruiting
Universitätskliniken des Saarlandes Kinderklinik
Homburg, 66424
GermanyActive - Recruiting
Klinikum der Otto von Guericke Universität
Magdeburg, 39120
GermanyTerminated
Klinikum Oldenburg
Oldenburg, 26133
GermanyTerminated
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona,
ItalySite Not Available
Ospedale di Bolzano
Bolzano, 39100
ItalyActive - Recruiting
Spedali Civili di Brescia
Brescia, 25100
ItalyTerminated
Azienda ospedaliera universitaria Meyer
Firenze, 50139
ItalySite Not Available
I.R.C.C.S. Giannina Gaslini
Genova, 16147
ItalyActive - Recruiting
U.O. Pediatria e Neonatologia Ospedale di Macerata
Macerata,
ItalyTerminated
Azienda Ospedaliera Universitaria II
Naples, 80138
ItalySite Not Available
Azienda Ospedaliera-Universitaria di Parma
Parma,
ItalySite Not Available
Azienda USL-IRCCS
Reggio Emilia,
ItalyActive - Recruiting
Ospedale Pediatrico Bambino
Roma, 00165
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù
Roma, 00165
ItalyActive - Recruiting
Hôpital Pierre Zobda Quitman
Fort-de-France, 97200
MartiniqueActive - Recruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Białystok, 15-274
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdańsk, 80-294
PolandActive - Recruiting
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, 20-093
PolandActive - Recruiting
Szpital kliniczny im. Karola Jonschnera
Poznań, 60-572
PolandActive - Recruiting
Kliniczny Szpital Wojewódzki
Rzeszów, 35-301
PolandActive - Recruiting
Pomeranian Medical University
Szczecin,
PolandActive - Recruiting
Hospital Parc Taulí de Sabadell
Barcelona, 08208
SpainActive - Recruiting
Hospital Sant Joan de Déu
Barcelona, 08950
SpainActive - Recruiting
Hospital Univ Vall d'Hebrón
Barcelona, 08035
SpainTerminated
Hospital Univ. de Cruces
Bilbao, 48903
SpainActive - Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
SpainActive - Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
SpainActive - Recruiting
Linköping University Hospital
Linkoping, 57850
SwedenActive - Recruiting
Karolinska Universitetssjukhuset
Stockholm, 17176
SwedenActive - Recruiting
Ipsen Central Contact
Slough, Berkshire
United KingdomSite Not Available
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BA
United KingdomActive - Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomTerminated
Leeds General Infirmary
Leeds, LS1 3EX
United KingdomActive - Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomActive - Recruiting
The Royal London Hospital
London, E1 1FR
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester, M13 0JH
United KingdomTerminated
Children's Hospital of Orange County
Orange, California 92868
United StatesActive - Recruiting
D&H National Research Centers
Miami, Florida 33155
United StatesSite Not Available
University Of Miami Leonard M. Miller
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami Leonard M Miller
Miami, Florida 33136
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Children's Health Specialty Center West Plano
Plano, Texas 75093
United StatesSite Not Available
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