Actively Recruiting

Age: 2Years - 18Years
All Genders
NCT00903110

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

Age: 2Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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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). | DecenTrialz