Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency

Last updated: July 7, 2020
Sponsor: Ipsen
Overall Status: Completed

Phase

2/3

Condition

Severe Short Stature

Treatment

N/A

Clinical Study ID

NCT00125190
MS308
2019-001095-11
  • Ages > 3
  • All Genders

Study Summary

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronological age ≥ 3

  • Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls

  • Prepubertal at Visit 1

  • Height SD score of < -2

  • IGF-1 SD score of < -2

Exclusion

Exclusion Criteria:

  • Prior treatment with GH, IGF-1, or other growth-influencing medications

  • Growth failure associated with other identifiable causes (e.g., syndromes, chromosomalabnormality)

  • Chronic illness such as diabetes, cystic fibrosis, etc.

Study Design

Total Participants: 45
Study Start date:
July 01, 2005
Estimated Completion Date:
January 31, 2009

Study Description

Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations [SDs] below the mean for age and gender), and abnormal serum IGF-1 (<-2 SDs below the mean for age and gender).

The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.

Connect with a study center

  • Ipsen

    Brisbane, California 94005
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.