RECRUITING

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).

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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).

Quick Facts

Study Start:2008-12-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00903110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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
  1. * Subject currently participating in an Increlex® clinical trial
  2. * Subject currently participating in any clinical trial for growth retardation
  3. * Patient with any contraindication to Increlex® or any condition subject to special warning as per the locally approved label
  4. * 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.
  5. * 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

Contacts and Locations

Study Contact

Ipsen Recruitment Enquiries
CONTACT
clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

Children's Hospital of Orange County
Orange, California, 92868
United States
University of Miami Leonard M Miller
Miami, Florida, 33136
United States
University Of Miami Leonard M. Miller
Miami, Florida, 33136
United States
D&H National Research Centers
Miami, Florida, 33155
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Children's Health Specialty Center West Plano
Plano, Texas, 75093
United States

Collaborators and Investigators

Sponsor: Ipsen

  • Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-12-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2008-12-09
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • IGF1 Deficiency