NCT00903110 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).
| NCT ID | NCT00903110 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Esteve Pharmaceuticals, S.A. |
| Condition | IGF1 Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2008-12-09 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2008-12-09 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Esteve Global Clinical Development
✉ increlexregistry@esteve.comGlobal Program Clinical Lead
STUDY DIRECTOR
Esteve
Frequently Asked Questions
Who can join the NCT00903110 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying IGF1 Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00903110 currently recruiting?
Yes, NCT00903110 is actively recruiting participants. Contact the research team at increlexregistry@esteve.com for enrollment information.
Where is the NCT00903110 trial being conducted?
This trial is being conducted at Orange, United States, Miami, United States, Miami, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT00903110 clinical trial?
NCT00903110 is sponsored by Esteve Pharmaceuticals, S.A.. The principal investigator is Global Program Clinical Lead at Esteve. The trial plans to enroll 500 participants.