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Monitoring the safety and effectiveness of Increlex® in children with IGF-1 deficiency

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. · NCT00903110

This study is tracking the safety and effectiveness of Increlex® treatment in children with a growth hormone deficiency to see how well it works over time.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages2 Years to 18 Years
SexAll
SponsorEsteve Pharmaceuticals, S.A. (industry)
Locations58 sites (Orange, California and 57 other locations)
Trial IDNCT00903110 on ClinicalTrials.gov

What this trial studies

This global registry collects and analyzes safety data for children and adolescents receiving Increlex® therapy for Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). It is a multicenter, observational, prospective registry that aims to monitor the long-term safety and effectiveness of the treatment. Data will be gathered from patients who are currently receiving Increlex® or have started treatment prior to entering the registry, allowing for both prospective and retrospective analysis. The registry spans multiple countries, including the USA and several European nations.

Who should consider this trial

Good fit: Ideal candidates include children and adolescents diagnosed with Severe Primary IGF-1 Deficiency who are starting or currently receiving Increlex® therapy.

Not a fit: Patients currently participating in other clinical trials for growth retardation or those with contraindications to Increlex® will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of Increlex® therapy, potentially improving treatment protocols for children with IGF-1 deficiency.

How similar studies have performed: Other observational studies have successfully monitored long-term safety and effectiveness of treatments in similar patient populations, suggesting this approach is validated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Orange, California and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: IGF1 Deficiency

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.