RecruitingNCT00903110

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).


Sponsor

Esteve Pharmaceuticals, S.A.

Enrollment

500 participants

Start Date

Dec 9, 2008

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Increlex® for people with igf1 deficiency. The study is currently recruiting participants at 58 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIncrelex®

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


Locations(58)

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

Azienda Ospedaliera Universitaria II

Naples, 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, 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

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NCT00903110