Recruiting

IncrelexGlobal 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).

Sponsor:

Esteve Pharmaceuticals, S.A.

Code:

NCT00903110

Conditions

IGF1 Deficiency

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Increlex®

Study Details

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.

Conditions

IGF1 Deficiency

Study ID

NCT00903110

Start date

Dec 9, 2008

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

Incidence of SAEs (including AESI of neoplasia) and all AEs, targeted AEs, deaths and withdrawals due to AEs. [ Time Frame: During the treatment period up to 30 days after the last dose. ]

Central Contacts and Locations

Central contacts

Esteve Global Clinical Development

increlexregistry@esteve.com

Locations

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

University of Miami Leonard M Miller

Recruiting

Miami, Florida, United States, 33136

University Of Miami Leonard M. Miller

Recruiting

Miami, Florida, United States, 33136

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Esteve Pharmaceuticals, S.A.

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Esteve Pharmaceuticals, S.A. on 2026-02-06.