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).

Last updated: April 29, 2025
Sponsor: Ipsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Increlex®

Clinical Study ID

NCT00903110
2-79-52800-002
EUPAS7708
  • Ages 2-18
  • All Genders

Study Summary

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.

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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Increlex®
Phase:
Study Start date:
December 09, 2008
Estimated Completion Date:
December 31, 2027

Study Description

This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe Primary IGF-1 Deficiency and secondly to follow the effectiveness of this treatment. Patients who have already started Increlex® therapy before entering this registry may be included and data will be collected retrospectively.

The countries participating in this registry are Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom and the USA

Connect with a study center

  • Salzkammergut-Klinik Vöcklabruck

    Vöcklabruck, A-4840
    Austria

    Active - Recruiting

  • Hôpital Amiens-Picardie

    Amiens, 80080
    France

    Terminated

  • Centre Hospitalier de Blois

    Blois, 41000
    France

    Active - Recruiting

  • Hôpital Jean Verdier

    Bondy, 93140
    France

    Active - Recruiting

  • Hôpital Femme Mère-Enfant

    Bron, 69500
    France

    Active - Recruiting

  • Hôpital Estaing

    Clermont-Ferrand, 63100
    France

    Active - Recruiting

  • Hôpital Timone Enfants

    Marseille, 13005
    France

    Active - Recruiting

  • Hôpital Arnaud de Villeneuve

    Montpellier, 34090
    France

    Active - Recruiting

  • GHR Mulhouse Sud-Alsace

    Mulhouse,
    France

    Terminated

  • Pole medical Bel'Air

    Mulhouse,
    France

    Active - Recruiting

  • CHU Lenval

    Nice, 06200
    France

    Site Not Available

  • Hôpital Kremlin Bicetre

    Paris, 97270
    France

    Active - Recruiting

  • Hôpital Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital des Enfants

    Toulouse, 31300
    France

    Active - Recruiting

  • Hôpital de Cayenne

    Cayenne, 97306
    French Guiana

    Site Not Available

  • Universitätsklinikum Erlangen Kinder- und Jugendklinik

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg Kinderheilkunde

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitätskliniken des Saarlandes Kinderklinik

    Homburg, 66424
    Germany

    Active - Recruiting

  • Klinikum der Otto von Guericke Universität

    Magdeburg, 39120
    Germany

    Terminated

  • Klinikum Oldenburg

    Oldenburg, 26133
    Germany

    Terminated

  • Diabetologia Pediatrica Azienda Ospedaliero-Universitaria

    Ancona,
    Italy

    Site Not Available

  • Ospedale di Bolzano

    Bolzano, 39100
    Italy

    Active - Recruiting

  • Spedali Civili di Brescia

    Brescia, 25100
    Italy

    Terminated

  • Azienda ospedaliera universitaria Meyer

    Firenze, 50139
    Italy

    Site Not Available

  • I.R.C.C.S. Giannina Gaslini

    Genova, 16147
    Italy

    Active - Recruiting

  • U.O. Pediatria e Neonatologia Ospedale di Macerata

    Macerata,
    Italy

    Terminated

  • Azienda Ospedaliera Universitaria II

    Naples, 80138
    Italy

    Site Not Available

  • Azienda Ospedaliera-Universitaria di Parma

    Parma,
    Italy

    Site Not Available

  • Azienda USL-IRCCS

    Reggio Emilia,
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino

    Roma, 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165
    Italy

    Active - Recruiting

  • Hôpital Pierre Zobda Quitman

    Fort-de-France, 97200
    Martinique

    Active - Recruiting

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny

    Białystok, 15-274
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80-294
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dziecięcy w Lublinie

    Lublin, 20-093
    Poland

    Active - Recruiting

  • Szpital kliniczny im. Karola Jonschnera

    Poznań, 60-572
    Poland

    Active - Recruiting

  • Kliniczny Szpital Wojewódzki

    Rzeszów, 35-301
    Poland

    Active - Recruiting

  • Pomeranian Medical University

    Szczecin,
    Poland

    Active - Recruiting

  • Hospital Parc Taulí de Sabadell

    Barcelona, 08208
    Spain

    Active - Recruiting

  • Hospital Sant Joan de Déu

    Barcelona, 08950
    Spain

    Active - Recruiting

  • Hospital Univ Vall d'Hebrón

    Barcelona, 08035
    Spain

    Terminated

  • Hospital Univ. de Cruces

    Bilbao, 48903
    Spain

    Active - Recruiting

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Linköping University Hospital

    Linkoping, 57850
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 17176
    Sweden

    Active - Recruiting

  • Ipsen Central Contact

    Slough, Berkshire
    United Kingdom

    Site Not Available

  • Royal Belfast Hospital for Sick Children

    Belfast, BT12 6BA
    United Kingdom

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Terminated

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • The Royal London Hospital

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 0JH
    United Kingdom

    Terminated

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Active - Recruiting

  • D&H National Research Centers

    Miami, Florida 33155
    United States

    Site Not Available

  • University Of Miami Leonard M. Miller

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Leonard M Miller

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Children's Health Specialty Center West Plano

    Plano, Texas 75093
    United States

    Site Not Available

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