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

Primary Insulin-like Growth Factor-1 Deficiency Clinical Trial

Official title:

Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00747604
• Other study ID #: W-TG-52800-010 (MS305)
• Status: Terminated
• Start date: June 2006
• Est. completion date: May 2014

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1378
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Primary Insulin-like Growth Factor-1 Deficiency

Intervention

Biological:
• mecasermin [rDNA origin] injection
As prescribed by the physician.

Locations

Country	Name	City	State
United States	Ipsen Central Contact	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure		periodically assessed over the course of the study