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).
Recruiting now
Conditions studied: IGF1 Deficiency
In brief
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.
Key facts
- Study ID
- NCT00903110
- Run by
- Esteve Pharmaceuticals, S.A.
- People needed
- 500
- Starts
- 2008-12-09
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-02-06
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (enrolling)
- Samodzielny Publiczny Dzieciecy Szpital Kliniczny — Bialystok, Poland (enrolling)
- I.R.C.C.S. Giannina Gaslini — Genova, Italy (enrolling)
- Azienda USL-IRCCS — Reggio Emilia, Italy (enrolling)
- University Of Miami Leonard M. Miller — Miami, Florida, United States (enrolling)
- Hôpital Pierre Zobda Quitman — Fort-de-France, Martinique (enrolling)
- Children's Hospital of Orange County — Orange, California, United States (enrolling)
- Ospedale di Bolzano — Bolzano, Italy (enrolling)
- Centre Hospitalier de Blois — Blois, France (enrolling)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
- Hôpital Femme Mère-Enfant — Bron, France (enrolling)
- Hôpital Estaing — Clermont-Ferrand, France (enrolling)
- Hôpital Timone Enfants — Marseille, France (enrolling)
- Hôpital Arnaud de Villeneuve — Montpellier, France (enrolling)
- Salzkammergut-Klinik Vöcklabruck — Vöcklabruck, Austria (enrolling)
- Pole medical Bel'Air — Mulhouse, France (enrolling)
- University of Miami Leonard M Miller — Miami, Florida, United States (enrolling)
- Hôpital Necker Enfants Malades — Paris, France (enrolling)
- Hôpital Kremlin Bicetre — Paris, France (enrolling)
- Hôpital des Enfants — Toulouse, France (enrolling)
- Hôpital Jean Verdier — Bondy, France (enrolling)
- Universitätsklinikum Erlangen Kinder- und Jugendklinik — Erlangen, Germany (enrolling)
- Universitätsklinikum Heidelberg Kinderheilkunde — Heidelberg, Germany (enrolling)
- Universitätskliniken des Saarlandes Kinderklinik — Homburg, Germany (enrolling)
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
Full record on ClinicalTrials.gov
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