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

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ClinicalTrials.gov Identifier: NCT00747604
Recruitment Status : Terminated (Shortage of Increlex supply)
First Posted : September 5, 2008
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
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 or disease Intervention/treatment
Primary Insulin-like Growth Factor-1 Deficiency Biological: mecasermin [rDNA origin] injection

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).


Study Type : Observational
Actual Enrollment : 1378 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Mecasermin
U.S. FDA Resources

Group/Cohort Intervention/treatment
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®



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747604


Locations
United States, New Jersey
Ipsen Central Contact
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Medical Director, Endocrinology Ipsen (formerly Tercica)

Additional Information:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00747604     History of Changes
Other Study ID Numbers: W-TG-52800-010 (MS305)
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Mecasermin
Growth Substances
Physiological Effects of Drugs