IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00747604
First received: September 3, 2008
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin [rDNA origin] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.


Condition Intervention
Primary Insulin-like Growth Factor-1 Deficiency
Biological: mecasermin [rDNA origin] injection

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure [ Time Frame: periodically assessed over the course of the study ] [ Designated as safety issue: Yes ]

Enrollment: 1378
Study Start Date: June 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Increlex patients
Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.
Biological: mecasermin [rDNA origin] injection
As prescribed by the physician.
Other Name: Increlex®

Detailed Description:

The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.

The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.

Criteria

Inclusion Criteria:

  • Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
  • Patients receiving Increlex® by a qualified practitioner may be enrolled

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747604

Locations
United States, New Jersey
Ipsen Central Contact
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Kathleen Lomax, M.D. Ipsen (formerly Tercica)
  More Information

Additional Information:
No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00747604     History of Changes
Other Study ID Numbers: W-TG-52800-010 (MS305)
Study First Received: September 3, 2008
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ipsen:
Growth Hormone (GH) Insensitivity Syndrome
Insulin-like Growth Factor Deficiency (IGFD)
Short Stature
Insulin-like Growth Factor (IGF-1)
Growth

ClinicalTrials.gov processed this record on July 20, 2014