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
AustriaSite Not Available
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck 2762343, A-4840
AustriaActive - Recruiting
Hôpital Amiens-Picardie
Amiens, 80080
FranceSite Not Available
Hôpital Amiens-Picardie
Amiens 3037854, 80080
FranceTerminated
Centre Hospitalier de Blois
Blois, 41000
FranceSite Not Available
Centre Hospitalier de Blois
Blois 3032213, 41000
FranceActive - Recruiting
Hôpital Jean Verdier
Bondy, 93140
FranceSite Not Available
Hôpital Jean Verdier
Bondy 3031815, 93140
FranceActive - Recruiting
Hôpital Femme Mère-Enfant
Bron, 69500
FranceSite Not Available
Hôpital Femme Mère-Enfant
Bron 3029931, 69500
FranceActive - Recruiting
Hôpital Estaing
Clermont-Ferrand, 63100
FranceSite Not Available
Hôpital Estaing
Clermont-Ferrand 3024635, 63100
FranceActive - Recruiting
Hôpital Timone Enfants
Marseille, 13005
FranceSite Not Available
Hôpital Timone Enfants
Marseille 2995469, 13005
FranceActive - Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34090
FranceSite Not Available
Hôpital Arnaud de Villeneuve
Montpellier 2992166, 34090
FranceActive - Recruiting
GHR Mulhouse Sud-Alsace
Mulhouse,
FranceTerminated
Pole medical Bel'Air
Mulhouse,
FranceSite Not Available
GHR Mulhouse Sud-Alsace
Mulhouse 2991214,
FranceTerminated
Pole medical Bel'Air
Mulhouse 2991214,
FranceActive - Recruiting
CHU Lenval
Nice, 06200
FranceSite Not Available
CHU Lenval
Nice 2990440, 06200
FranceSite Not Available
Hôpital Kremlin Bicetre
Paris, 97270
FranceSite Not Available
Hôpital Necker Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Kremlin Bicetre
Paris 2988507, 97270
FranceActive - Recruiting
Hôpital Necker Enfants Malades
Paris 2988507, 75015
FranceActive - Recruiting
Hôpital des Enfants
Toulouse, 31300
FranceSite Not Available
Hôpital des Enfants
Toulouse 2972315, 31300
FranceActive - Recruiting
Hôpital de Cayenne
Cayenne, 97306
French GuianaSite Not Available
Hôpital de Cayenne
Cayenne 3382160, 97306
French GuianaSite Not Available
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, 91054
GermanySite Not Available
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen 2929567, 91054
GermanyActive - Recruiting
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg 2907911, 69120
GermanyActive - Recruiting
Universitätskliniken des Saarlandes Kinderklinik
Homburg, 66424
GermanySite Not Available
Universitätskliniken des Saarlandes Kinderklinik
Homburg 2899449, 66424
GermanyActive - Recruiting
Klinikum der Otto von Guericke Universität
Magdeburg, 39120
GermanySite Not Available
Klinikum der Otto von Guericke Universität
Magdeburg 2874545, 39120
GermanyTerminated
Klinikum Oldenburg
Oldenburg, 26133
GermanySite Not Available
Klinikum Oldenburg
Oldenburg 2857458, 26133
GermanyTerminated
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona,
ItalySite Not Available
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona 3183089,
ItalySite Not Available
Ospedale di Bolzano
Bolzano, 39100
ItalySite Not Available
Ospedale di Bolzano
Bolzano 3181913, 39100
ItalyActive - Recruiting
Spedali Civili di Brescia
Brescia, 25100
ItalySite Not Available
Spedali Civili di Brescia
Brescia 3181554, 25100
ItalyTerminated
Azienda ospedaliera universitaria Meyer
Firenze, 50139
ItalySite Not Available
Azienda ospedaliera universitaria Meyer
Florence 3176959, 50139
ItalySite Not Available
I.R.C.C.S. Giannina Gaslini
Genova, 16147
ItalySite Not Available
I.R.C.C.S. Giannina Gaslini
Genova 8969657, 16147
ItalyActive - Recruiting
U.O. Pediatria e Neonatologia Ospedale di Macerata
Macerata,
ItalySite Not Available
U.O. Pediatria e Neonatologia Ospedale di Macerata
Macerata 3174380,
ItalyTerminated
Azienda Ospedaliera Universitaria II
Naples, 80138
ItalySite Not Available
Azienda Ospedaliera Universitaria II
Naples 3172394, 80138
ItalySite Not Available
Azienda Ospedaliera-Universitaria di Parma
Parma,
ItalySite Not Available
Azienda Ospedaliera-Universitaria di Parma
Parma 3171457,
ItalySite Not Available
Azienda USL-IRCCS
Reggio Emilia,
ItalySite Not Available
Azienda USL-IRCCS
Reggio Emilia 3169522,
ItalyActive - Recruiting
Ospedale Pediatrico Bambino
Roma, 00165
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù
Roma, 00165
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù
Roma 8957247, 00165
ItalyActive - Recruiting
Hôpital Pierre Zobda Quitman
Fort-de-France, 97200
MartiniqueSite Not Available
Hôpital Pierre Zobda Quitman
Fort-de-France 3570675, 97200
MartiniqueActive - Recruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok 776069, 15-274
PolandActive - Recruiting
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Białystok, 15-274
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, 80-294
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdańsk, 80-294
PolandSite Not Available
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, 20-093
PolandSite Not Available
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin 765876, 20-093
PolandActive - Recruiting
Szpital kliniczny im. Karola Jonschnera
Poznan 3088171, 60-572
PolandActive - Recruiting
Szpital kliniczny im. Karola Jonschnera
Poznań, 60-572
PolandSite Not Available
Kliniczny Szpital Wojewódzki
Rzeszów, 35-301
PolandSite Not Available
Kliniczny Szpital Wojewódzki
Rzeszów 759734, 35-301
PolandActive - Recruiting
Pomeranian Medical University
Szczecin,
PolandSite Not Available
Pomeranian Medical University
Szczecin 3083829,
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
SpainSite Not Available
Hospital Parc Taulí de Sabadell
Barcelona 3128760, 08208
SpainActive - Recruiting
Hospital Sant Joan de Déu
Barcelona 3128760, 08950
SpainActive - Recruiting
Hospital Univ Vall d'Hebrón
Barcelona 3128760, 08035
SpainTerminated
Hospital Univ. de Cruces
Bilbao, 48903
SpainSite Not Available
Hospital Univ. de Cruces
Bilbao 3128026, 48903
SpainActive - Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
SpainSite Not Available
Hospital Universitari Sant Joan de Reus
Reus 3111933, 43204
SpainActive - Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
SpainSite Not Available
Hospital Universitario y Politécnico La Fe
Valencia 2509954, 46026
SpainActive - Recruiting
Linköping University Hospital
Linkoping, 57850
SwedenSite Not Available
Linköping University Hospital
Linköping 2694762, 57850
SwedenActive - Recruiting
Karolinska Universitetssjukhuset
Stockholm, 17176
SwedenSite Not Available
Karolinska Universitetssjukhuset
Stockholm 2673730, 17176
SwedenActive - Recruiting
Ipsen Central Contact
Slough, Berkshire
United KingdomSite Not Available
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BA
United KingdomSite Not Available
Royal Belfast Hospital for Sick Children
Belfast 2655984, BT12 6BA
United KingdomActive - Recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
United KingdomSite Not Available
Birmingham Children's Hospital
Birmingham 2655603, B4 6NH
United KingdomTerminated
Leeds General Infirmary
Leeds, LS1 3EX
United KingdomSite Not Available
Leeds General Infirmary
Leeds 2644688, LS1 3EX
United KingdomActive - Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
United KingdomSite Not Available
The Royal London Hospital
London, E1 1FR
United KingdomActive - Recruiting
Great Ormond Street Hospital
London 2643743, WC1N 3JH
United KingdomActive - Recruiting
The Royal London Hospital
London 2643743, E1 1FR
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester, M13 0JH
United KingdomSite Not Available
Royal Manchester Children's Hospital
Manchester 2643123, M13 0JH
United KingdomTerminated
Children's Hospital of Orange County
Orange, California 92868
United StatesSite Not Available
Children's Hospital of Orange County
Orange 5379513, California 5332921 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 StatesSite Not Available
D&H National Research Centers
Miami 4164138, Florida 4155751 33155
United StatesSite Not Available
University Of Miami Leonard M. Miller
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
University of Miami Leonard M Miller
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 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
UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
Children's Health Specialty Center West Plano
Plano 4719457, Texas 4736286 75093
United StatesSite Not Available

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