Actively Recruiting
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).
Led by Esteve Pharmaceuticals, S.A. · Updated on 2026-02-06
500
Participants Needed
58
Research Sites
994 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients starting, planning to start, or currently receiving Increlex4 therapy for severe primary IGF-1 deficiency or growth hormone gene deletion with neutralizing antibodies to growth hormone
- For EU patients, treatment according to locally approved product information
- Signed informed consent from parents or legal representatives, with assent from the child as appropriate
You will not qualify if you...
- Currently participating in an Increlex4 clinical trial
- Currently participating in any clinical trial for growth retardation
- Any contraindication to Increlex4 or conditions with special warnings per local label
- For US patients: hypersensitivity to Increlex4, active or suspected neoplasia, or closed growth plates
- For EU patients: hypersensitivity to Increlex4, active or suspected neoplasia, medical history increasing risk of tumors, or closed growth plates
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
2
University of Miami Leonard M Miller
Miami, Florida, United States, 33136
Actively Recruiting
3
University Of Miami Leonard M. Miller
Miami, Florida, United States, 33136
Actively Recruiting
4
D&H National Research Centers
Miami, Florida, United States, 33155
Withdrawn
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
7
Children's Health Specialty Center West Plano
Plano, Texas, United States, 75093
Withdrawn
8
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, Austria, A-4840
Actively Recruiting
9
Hôpital Amiens-Picardie
Amiens, France, 80080
Terminated
10
Centre Hospitalier de Blois
Blois, France, 41000
Actively Recruiting
11
Hôpital Jean Verdier
Bondy, France, 93140
Actively Recruiting
12
Hôpital Femme Mère-Enfant
Bron, France, 69500
Actively Recruiting
13
Hôpital Estaing
Clermont-Ferrand, France, 63100
Actively Recruiting
14
Hôpital Timone Enfants
Marseille, France, 13005
Actively Recruiting
15
Hôpital Arnaud de Villeneuve
Montpellier, France, 34090
Actively Recruiting
16
GHR Mulhouse Sud-Alsace
Mulhouse, France
Terminated
17
Pole medical Bel'Air
Mulhouse, France
Actively Recruiting
18
CHU Lenval
Nice, France, 06200
Withdrawn
19
Hôpital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
20
Hôpital Kremlin Bicetre
Paris, France, 97270
Actively Recruiting
21
Hôpital des Enfants
Toulouse, France, 31300
Actively Recruiting
22
Hôpital de Cayenne
Cayenne, French Guiana, 97306
Withdrawn
23
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, Germany, 91054
Actively Recruiting
24
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, Germany, 69120
Actively Recruiting
25
Universitätskliniken des Saarlandes Kinderklinik
Homburg, Germany, 66424
Actively Recruiting
26
Klinikum der Otto von Guericke Universität
Magdeburg, Germany, 39120
Terminated
27
Klinikum Oldenburg
Oldenburg, Germany, 26133
Terminated
28
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona, Italy
Not Yet Recruiting
29
Ospedale di Bolzano
Bolzano, Italy, 39100
Actively Recruiting
30
Spedali Civili di Brescia
Brescia, Italy, 25100
Terminated
31
Azienda ospedaliera universitaria Meyer
Florence, Italy, 50139
Not Yet Recruiting
32
I.R.C.C.S. Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
33
Azienda Ospedaliera Universitaria II
Naples, Italy, 80138
Not Yet Recruiting
34
Azienda Ospedaliera-Universitaria di Parma
Parma, Italy
Not Yet Recruiting
35
U.O. Pediatria e Neonatologia Ospedale di Macerata
Province of Macerata, Italy
Terminated
36
Azienda USL-IRCCS
Reggio Emilia, Italy
Actively Recruiting
37
Ospedale Pediatrico Bambino Gesù
Roma, Italy, 00165
Actively Recruiting
38
Hôpital Pierre Zobda Quitman
Fort-de-France, Martinique, 97200
Actively Recruiting
39
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, Poland, 15-274
Actively Recruiting
40
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-294
Actively Recruiting
41
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, Poland, 20-093
Actively Recruiting
42
Szpital kliniczny im. Karola Jonschnera
Poznan, Poland, 60-572
Actively Recruiting
43
Kliniczny Szpital Wojewódzki
Rzeszów, Poland, 35-301
Actively Recruiting
44
Pomeranian Medical University
Szczecin, Poland
Actively Recruiting
45
Hospital Univ Vall d'Hebrón
Barcelona, Spain, 08035
Terminated
46
Hospital Parc Taulí de Sabadell
Barcelona, Spain, 08208
Actively Recruiting
47
Hospital Sant Joan de Déu
Barcelona, Spain, 08950
Actively Recruiting
48
Hospital Univ. de Cruces
Bilbao, Spain, 48903
Actively Recruiting
49
Hospital Universitari Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
50
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
51
Linköping University Hospital
Linköping, Sweden, 57850
Actively Recruiting
52
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
Actively Recruiting
53
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom, BT12 6BA
Actively Recruiting
54
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Terminated
55
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
56
The Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
57
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
58
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 0JH
Terminated
Research Team
E
Esteve Global Clinical Development
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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