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).
NCT ID: NCT00903110
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2008-12-09
2027-12-31
Brief Summary
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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.
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Detailed Description
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The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA
Conditions
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Study Design
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CASE_ONLY
OTHER
Interventions
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Increlex®
Increlex® (mecasermin \[rDNA origin\] injection), 10 mg/ml solution for injection, 40-120mcg/kg BID or 0,04 to 0,12 mg/kg BID, as prescribed by physician
Eligibility Criteria
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Inclusion Criteria
* Parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. Assent from the subject should also be obtained as appropriate
Exclusion Criteria
* Subject currently participating in any clinical trial for growth retardation
* Patient with any contraindication to Increlex® or any condition subject to special warning as per the locally approved label
* For US patients, these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia and patients with closed epiphyses.
* For EU patients: these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia or any condition or medical history which increases the risk of benign or malignant neoplasia and patients with closed epiphyses
2 Years
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Children's Hospital of Orange County
Orange, California, United States
University of Miami Leonard M Miller
Miami, Florida, United States
University Of Miami Leonard M. Miller
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Children's Health Specialty Center West Plano
Plano, Texas, United States
Salzkammergut-Klinik Vöcklabruck
Vöcklabruck, , Austria
Hôpital Amiens-Picardie
Amiens, , France
Centre Hospitalier de Blois
Blois, , France
Hôpital Jean Verdier
Bondy, , France
Hôpital Femme Mère-Enfant
Bron, , France
Hôpital Estaing
Clermont-Ferrand, , France
Hôpital Timone Enfants
Marseille, , France
Hôpital Arnaud de Villeneuve
Montpellier, , France
GHR Mulhouse Sud-Alsace
Mulhouse, , France
Pole medical Bel'Air
Mulhouse, , France
CHU Lenval
Nice, , France
Hôpital Necker Enfants Malades
Paris, , France
Hôpital Kremlin Bicetre
Paris, , France
Hôpital des Enfants
Toulouse, , France
Hôpital de Cayenne
Cayenne, , French Guiana
Universitätsklinikum Erlangen Kinder- und Jugendklinik
Erlangen, , Germany
Universitätsklinikum Heidelberg Kinderheilkunde
Heidelberg, , Germany
Universitätskliniken des Saarlandes Kinderklinik
Homburg, , Germany
Klinikum der Otto von Guericke Universität
Magdeburg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Diabetologia Pediatrica Azienda Ospedaliero-Universitaria
Ancona, , Italy
Ospedale di Bolzano
Bolzano, , Italy
Spedali Civili di Brescia
Brescia, , Italy
Azienda ospedaliera universitaria Meyer
Florence, , Italy
I.R.C.C.S. Giannina Gaslini
Genova, , Italy
U.O. Pediatria e Neonatologia Ospedale di Macerata
Macerata, , Italy
Azienda Ospedaliera Universitaria II
Naples, , Italy
Azienda Ospedaliera-Universitaria di Parma
Parma, , Italy
Azienda USL-IRCCS
Reggio Emilia, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Hôpital Pierre Zobda Quitman
Fort-de-France, , Martinique
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin, , Poland
Szpital kliniczny im. Karola Jonschnera
Poznan, , Poland
Kliniczny Szpital Wojewódzki
Rzeszów, , Poland
Pomeranian Medical University
Szczecin, , Poland
Hospital Univ Vall d'Hebrón
Barcelona, , Spain
Hospital Parc Taulí de Sabadell
Barcelona, , Spain
Hospital Sant Joan de Déu
Barcelona, , Spain
Hospital Univ. de Cruces
Bilbao, , Spain
Hospital Universitari Sant Joan de Reus
Reus, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Linköping University Hospital
Linköping, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Z
Role: primary
References
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Bang P, Polak M, Bossowski A, Maghnie M, Argente J, Ramon-Krauel M, Sert C, Perrot V, Mazain S, Woelfle J. Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry. J Clin Endocrinol Metab. 2023 Dec 21;109(1):46-56. doi: 10.1210/clinem/dgad479.
Bang P, Polak M, Perrot V, Sert C, Shaikh H, Woelfle J. Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex(R) Growth Forum Database Registry. Front Endocrinol (Lausanne). 2022 Feb 18;13:812568. doi: 10.3389/fendo.2022.812568. eCollection 2022.
Bang P, Woelfle J, Perrot V, Sert C, Polak M. Effectiveness and safety of rhIGF1 therapy in patients with or without Laron syndrome. Eur J Endocrinol. 2021 Feb;184(2):267-276. doi: 10.1530/EJE-20-0325.
Other Identifiers
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EUPAS7708
Identifier Type: OTHER
Identifier Source: secondary_id
2-79-52800-002
Identifier Type: -
Identifier Source: org_study_id
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