Primary outcomeMean· Pretreatment to Week 34
Height Velocity From Pretreatment (Week 0) to Week 34
| Group | Value (centimeters per year (cm/yr)) | Spread |
|---|---|---|
| rhIGF-1 QD | 7.0 | 1.5 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataRecombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
NCTNCT00125190 (opens ClinicalTrials.gov in a new tab)Other idMS308Other id2019-001095-11Other id2019
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 45 participants (actual)
- Sponsor
- Ipsen · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- Jul 2005
- Primary completion
- Jan 2009
- Completion
- Jan 2009
- First posted
- 29 Jul 2005 (estimated)
- Last update posted
- 27 Jul 2020
- Conditions
- Insulin-Like Growth Factor-1 Deficiency · Growth Disorders
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200520062007200820092010
- Ph 2/3
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
NCT00125190Jul 2005 to Jan 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- rhIGF-1 (mecasermin) for a period of 86 weeksDrug
Arms1
Experimental
rhIGF-1 QD
Subjects received subcutaneous injection (SC) injections of rhIGF-1 once a day.
Primary outcomes2
Outcomes the sponsor listed as primary.
Height Velocity From Pretreatment (Week 0) to Week 34
Time frame · Pretreatment to Week 34
Registry description
Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 34 heights were imputed using the last height SD score carried forward.
Height Velocity From Week 34 to 86
Time frame · Week 34 to 86
Registry description
Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 86 heights were imputed using the last height SD score carried forward.
Secondary outcomes(5)
Change in Height SD Score From Pretreatment to Week 34
Time frame · Pretreatment and Week 34
Registry description
Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. The subject was repositioned between each measurement. The SD score is calculated as the subject value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
Change in Height SD Score From Pretreatment to Week 86
Time frame · Pretreatment and Week 86
Registry description
Height was measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Subjects were repositioned between each measurement. The SD score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age
Time frame · Pretreatment to Week 86
Registry description
Plain X-rays of the left hand and wrist were exposed for bone age appraisal. The films were sent to a central facility for standardized evaluation.
Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86
Time frame · Pretreatment and Week 86
Registry description
Growth factor panels for measuring IGFBP-1, IGFBP-2 and IGFBP-3 were evaluated from screening and at each study visit up to Week 86. Inter-quartile range (Q1-Q3) is 10th to 90th percentile.
Percent Change in Serum Concentration of ALS From Pretreatment to Week 86
Time frame · Pretreatment and Week 86
Registry description
Growth factor panels for measuring ALS were evaluated from screening and at each study visit up to Week 86. Inter-quartile range (Q1-Q3) is 10th to 90th percentile.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Week 34 to 86
Height Velocity From Week 34 to 86
| Group | Value (cm/yr) | Spread |
|---|---|---|
| rhIGF-1 QD | 6.7 | 1.8 |
Secondary and other outcome results(6)
Secondary outcomeMean· Pretreatment and Week 34
Change in Height SD Score From Pretreatment to Week 34
| Group | Value (SDs) | Spread |
|---|---|---|
| rhIGF-1 QD | 0.21 | 0.20 |
Secondary outcomeMean· Pretreatment and Week 86
Change in Height SD Score From Pretreatment to Week 86
| Group | Value (SDs) | Spread |
|---|---|---|
| rhIGF-1 QD | 0.45 | 0.39 |
Secondary outcomeMean· Pretreatment to Week 86
Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age
| Group | Value (years) | Spread |
|---|---|---|
| rhIGF-1 QD | 0.2 | 0.68 |
Secondary outcomeMedian· Pretreatment and Week 86
Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86
| Group | Value (percent change) |
|---|---|
| rhIGF-1 QD | -89.6 |
Secondary outcomeMedian· Pretreatment and Week 86
Percent Change in Serum Concentration of ALS From Pretreatment to Week 86
| Group | Value (percent change) |
|---|---|
| rhIGF-1 QD | -7.7 |
Post hoc outcomeMean· Pretreatment to Week 34
Increase in Height Velocity From Pretreatment to Week 34
| Group | Value (cm/yr) | Spread |
|---|---|---|
| rhIGF-1 QD | 1.3 | 3.56 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| rhIGF-1 QDDuring the treatment phase (Day 1 to Week 86), subjects received SC injections of rhIGF-1 at an initial dose of 60 mcg/kg QD starting on Day 1 (Visit 3). From Week 2 (Visit 4) subsequent dose adjustments were made in order to achieve the target serum IGF-1 concentration for the subject's age and sex. The maximum dose in any circumstance was 240 mcg/kg/day. | 0 / 45 | 2 / 45 | 41 / 45 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 3 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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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