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NCT00903110Recruiting

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).

Esteve Pharmaceuticals, S.A.

Start Date

12/9/2008

Completion Date

12/31/2027

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.

Detailed 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

Eligibility Criteria

Age Range: 2 years to 18 years

Inclusion Criteria: * For US : patients starting or planning to start or currently receiving treatment with Increlex® therapy for severe primary IGF-1 deficiency as defined by the US Increlex® prescribing information or for growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.For EU : patients starting or planning to start or currently receiving treatment with Increlex® therapy according to the locally approved product information. * 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 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 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

Interventions

DRUG

Increlex®

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Conditions

IGF1 Deficiency

Locations

Children's Hospital of Orange County

Orange, California 92868

United States

University of Miami Leonard M Miller

Miami, Florida 33136

United States

University Of Miami Leonard M. Miller

Miami, Florida 33136

United States

D&H National Research Centers

Miami, Florida 33155

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Children's Health Specialty Center West Plano

Plano, Texas 75093

United States

Salzkammergut-Klinik Vöcklabruck

Vöcklabruck, A-4840

Austria

Hôpital Amiens-Picardie

Amiens, 80080

France

Centre Hospitalier de Blois

Blois, 41000

France

Hôpital Jean Verdier

Bondy, 93140

France

Hôpital Femme Mère-Enfant

Bron, 69500

France

Hôpital Estaing

Clermont-Ferrand, 63100

France

Hôpital Timone Enfants

Marseille, 13005

France

Hôpital Arnaud de Villeneuve

Montpellier, 34090

France

GHR Mulhouse Sud-Alsace

Mulhouse,

France

Pole medical Bel'Air

Mulhouse,

France

CHU Lenval

Nice, 06200

France

Hôpital Necker Enfants Malades

Paris, 75015

France

Hôpital Kremlin Bicetre

Paris, 97270

France

Hôpital des Enfants

Toulouse, 31300

France

Hôpital de Cayenne

Cayenne, 97306

French Guiana

Universitätsklinikum Erlangen Kinder- und Jugendklinik

Erlangen, 91054

Germany

Universitätsklinikum Heidelberg Kinderheilkunde

Heidelberg, 69120

Germany

Universitätskliniken des Saarlandes Kinderklinik

Homburg, 66424

Germany

Klinikum der Otto von Guericke Universität

Magdeburg, 39120

Germany

Klinikum Oldenburg

Oldenburg, 26133

Germany

Diabetologia Pediatrica Azienda Ospedaliero-Universitaria

Ancona,

Italy

Ospedale di Bolzano

Bolzano, 39100

Italy

Spedali Civili di Brescia

Brescia, 25100

Italy

Azienda ospedaliera universitaria Meyer

Florence, 50139

Italy

I.R.C.C.S. Giannina Gaslini

Genova, 16147

Italy

Azienda Ospedaliera Universitaria II

Naples, 80138

Italy

Azienda Ospedaliera-Universitaria di Parma

Parma,

Italy

U.O. Pediatria e Neonatologia Ospedale di Macerata

Province of Macerata,

Italy

Azienda USL-IRCCS

Reggio Emilia,

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 00165

Italy

Hôpital Pierre Zobda Quitman

Fort-de-France, 97200

Martinique

Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Bialystok, 15-274

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-294

Poland

Uniwersytecki Szpital Dziecięcy w Lublinie

Lublin, 20-093

Poland

Szpital kliniczny im. Karola Jonschnera

Poznan, 60-572

Poland

Kliniczny Szpital Wojewódzki

Rzeszów, 35-301

Poland

Pomeranian Medical University

Szczecin,

Poland

Hospital Univ Vall d'Hebrón

Barcelona, 08035

Spain

Hospital Parc Taulí de Sabadell

Barcelona, 08208

Spain

Hospital Sant Joan de Déu

Barcelona, 08950

Spain

Hospital Univ. de Cruces

Bilbao, 48903

Spain

Hospital Universitari Sant Joan de Reus

Reus, 43204

Spain

Hospital Universitario y Politécnico La Fe

Valencia, 46026

Spain

Linköping University Hospital

Linköping, 57850

Sweden

Karolinska Universitetssjukhuset

Stockholm, 17176

Sweden

Royal Belfast Hospital for Sick Children

Belfast, BT12 6BA

United Kingdom

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Leeds General Infirmary

Leeds, LS1 3EX

United Kingdom

The Royal London Hospital

London, E1 1FR

United Kingdom

Great Ormond Street Hospital

London, WC1N 3JH

United Kingdom

Royal Manchester Children's Hospital

Manchester, M13 0JH

United Kingdom