| July 27, 2005 |
| October 28, 2009 |
| July 2005 |
| January 2009 (final data collection date for primary outcome measure) |
| Increase in height velocity over the study period [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ] |
| Increase in height velocity over the study period |
| Complete list of historical versions of study NCT00125190 on ClinicalTrials.gov Archive Site |
- Changes in serum concentration of insulin-like growth factor binding-1 (IGFBP-1, IGFBP-2, IGFBP-3) and acid labile subunit (ALS) [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
- Changes in height standard deviation (SD) score over one year [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
- Changes in bone age over one year [ Time Frame: One year ] [ Designated as safety issue: No ]
- rhIGF-1 doses required to achieve the serum IGF-1 targets with measures taken at each study visit [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
|
- 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
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| |
| Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency |
| Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study |
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. |
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. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
- Insulin-Like Growth Factor-1 Deficiency
- Growth Disorders
|
| Drug: rhIGF-1 (mecasermin) for a period of 86 weeks |
| |
| |
| |
| Completed |
| 45 |
| April 2009 |
| January 2009 (final data collection date for primary outcome measure) |
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 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.
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| Both |
| 3 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00125190 |
| Sandra Blethen, MD, Tercica, Inc |
| MS308 |
| Tercica |
| Ipsen |
| Study Director: |
George Bright, M.D. |
Tercica, Inc. |
|
|
| Tercica |
| October 2009 |
