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).

Plain-language summary

This is a registry monitoring the long-term safety and effectiveness of the drug Increlex in children and adolescents with severe primary Insulin-like Growth Factor-1 (IGF-1) deficiency. It enrolls patients receiving or planning Increlex therapy for IGF-1 deficiency. It is an observational (non-phase) registry and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Esteve Pharmaceuticals, S.A.

Intervention

Increlex®

Start date

12/9/2008

Estimated completion

12/31/2027

Countries

United States, Austria, France, French Guiana, Germany, Italy, Martinique, Poland, Spain, Sweden, United Kingdom

Related genes

Locations

• Orange, United States
• Miami, United States
• Miami, United States
• Miami, United States
• Cincinnati, United States
• Dallas, United States
• Plano, United States
• Vöcklabruck, Austria
• Amiens, France
• Blois, France
• Bondy, France
• Bron, France
• Clermont-Ferrand, France
• Marseille, France
• Montpellier, France
• Mulhouse, France
• Mulhouse, France
• Nice, France
• Paris, France
• Paris, France
• Toulouse, France
• Cayenne, French Guiana
• Erlangen, Germany
• Heidelberg, Germany
• Homburg, Germany
• Magdeburg, Germany
• Oldenburg, Germany
• Ancona, Italy
• Bolzano, Italy
• Brescia, Italy
• Florence, Italy
• Genova, Italy
• Naples, Italy
• Parma, Italy
• Province of Macerata, Italy
• Reggio Emilia, Italy
• Roma, Italy
• Fort-de-France, Martinique
• Bialystok, Poland
• Gdansk, Poland

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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