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

NCT ID: NCT00747604

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Primary Insulin-like Growth Factor-1 Deficiency

Keywords

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Growth Hormone (GH) Insensitivity Syndrome Insulin-like Growth Factor Deficiency (IGFD) Short Stature Insulin-like Growth Factor (IGF-1) Growth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Increlex patients

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

mecasermin [rDNA origin] injection

Intervention Type BIOLOGICAL

As prescribed by the physician.

Interventions

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mecasermin [rDNA origin] injection

As prescribed by the physician.

Intervention Type BIOLOGICAL

Other Intervention Names

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Increlex®

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, Endocrinology

Role: STUDY_DIRECTOR

Ipsen (formerly Tercica)

Locations

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Ipsen Central Contact

Basking Ridge, New Jersey, United States

Site Status

Countries

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France United States

Other Identifiers

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W-TG-52800-010 (MS305)

Identifier Type: -

Identifier Source: org_study_id