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Long-Term Treatment With rhIGF-1 in GHIS

NCT00571727 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-07-06

Study results available
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Summary

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Conditions

  • Growth Hormone Insensitivity Syndrome

Interventions

DRUG

mecasermin

injections BID of rhIGF-1, mecasermin

Sponsors & Collaborators

  • University of Oklahoma

    collaborator OTHER

  • Ipsen

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-05-20
Primary Completion
2011-12-15
Completion
2011-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571727 on ClinicalTrials.gov