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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).

NCT00903110 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • IGF1 Deficiency

Interventions

DRUG

Increlex®

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

Sponsors & Collaborators

  • Esteve Pharmaceuticals, S.A.

    lead INDUSTRY

Principal Investigators

  • Global Program Clinical Lead · Esteve

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-09
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903110 on ClinicalTrials.gov