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.

Condition	Intervention
Insulin-Like Growth Factor-1 Deficiency Primary IGF-1 Deficiency IGF-1	Drug: rhIGF-1 (mecasermin, Tercica, Inc.) for a period of 1 year

Further Study Details: 

Primary Outcomes: Increase in Height Velocity over the study period
Secondary Outcomes: Changes in serum concentration of insulin-like growth factor binding-1 (IGFBP-1, IGFBP-2, IGFBP-3) and acid labile subunit (ALS); Changes in height SD score over one year; Changes in bone age over one year; rhIGF-1 doses required to achieve the serum IGF-1 targets with measures taken at each study visit
Expected Total Enrollment:  45

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 GH action. In this protocol, Primary IGFD is defined as short stature (<-2 standard deviations (SDs) below the mean for age and gender), 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 through out the United States.

Ages Eligible for Study:  3 Years   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Chronological age ≥ 3,
• Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls
• Prepubertal at Visit 1.
• Height SDS < –2
• IGF-1 SDS < –2

Exclusion Criteria:

• Prior treatment with GH, IGF-1, or other growth-influencing medications
• Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
• Chronic illness such as diabetes, cystic fibrosis, etc.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125190

Thorsten von Stein, M.D., Ph.D.      650 624 4919    thorsten.vonstein@tercica.com
Elizabeth Lawson      650 238 1545    elizabeth.lawson@tercica.com

California
      Tercica, Inc., Brisbane,  California,  94005,  United States; Recruiting

Study chairs or principal investigators

George Bright, M.D.,  Study Director,  Tercica, Inc.   

Study ID Numbers:  MS308
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125190
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02