Trial · NCT00125164
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
NCT00125164, Phase 3, Completed, Ipsen; results first posted 2010-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency. Trials, record NCT00125164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00125164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
- NCT number
- NCT00125164
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Growth Disorders, Insulin-Like Growth Factor-1 Deficiency
- Interventions
- rhIGF-1 (mecasermin, Tercica, Inc.)
- First posted
- 2005-07-29
- Last updated
- 2019-09-18
- Other registries' IDs
- eudract:2019-001020-36
- Results first posted
- 2010-04-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Velocity During the First Year - Intent to Treat (ITT)Population | Measured at baseline and at one year | Height to be 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. Reposition subject between each measurement. |
| Secondary | Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | Measured at baseline and at one year | Height to be 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. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. 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. |
| Secondary | Changes in Bone Age From Baseline to One Year | Measured at baseline and at one year | Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation. |
| Secondary | Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year | Measured at baseline and at one year | Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel. |
| Secondary | Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year | Measured at baseline and at one year | Blood sample was collected for measuring the level of IGF-2 in the growth factor panel. |
| Secondary | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year | Measured at baseline and at one year | Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel. |
| Secondary | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year | Measured at baseline and at one year | Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel. |
| Secondary | IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Study Day 1 and Day 7 | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. |
| Secondary | IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Study Day 1 and Day 7 | Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7. |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Height Velocity During the First Year - Intent to Treat (ITT)Population | Measured at baseline and at one year | A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | cm/yr | MEAN |
| SECONDARY | Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | Measured at baseline and at one year | A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | SD/year | MEAN |
| SECONDARY | Changes in Bone Age From Baseline to One Year | Measured at baseline and at one year | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Year | MEAN |
| SECONDARY | Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year | Measured at baseline and at one year | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Percent change | MEAN |
| SECONDARY | Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year | Measured at baseline and at one year | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Percent change | MEAN |
| SECONDARY | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year | Measured at baseline and at one year | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Percent change | MEAN |
| SECONDARY | Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year | Measured at baseline and at one year | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | Percent change | MEAN |
| SECONDARY | IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Study Day 1 and Day 7 | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | ng/mL | MEAN |
| SECONDARY | IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH) | Study Day 1 and Day 7 | All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | mg/dL | MEAN |
| POST_HOC | Height Velocity During the First Year for Subjects - Completers | One Year | All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID. | cm/year | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Height Velocity During the First Year - Intent to Treat (ITT)Population | Untreated | 5.2 | Standard Deviation 1.0 | cm/yr | |
| Height Velocity During the First Year - Intent to Treat (ITT)Population | 80 μg/kg BID (Twice Daily Dosing) | 6.9 | Standard Deviation 1.0 | cm/yr | |
| Height Velocity During the First Year - Intent to Treat (ITT)Population | 120 μg/kg BID (Twice Daily Dosing) | 7.7 | Standard Deviation 1.5 | cm/yr | |
| Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | Untreated | 0.02 | Standard Deviation 0.24 | SD/year | |
| Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | 80 μg/kg BID (Twice Daily Dosing) | 0.38 | Standard Deviation 0.17 | SD/year | |
| Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population | 120 μg/kg BID (Twice Daily Dosing) | 0.48 | Standard Deviation 0.32 | SD/year | |
| Changes in Bone Age From Baseline to One Year | Untreated | 0.8 | Standard Deviation 0.3 | Year | |
| Changes in Bone Age From Baseline to One Year | 80 μg/kg BID (Twice Daily Dosing) | 1.1 | Standard Deviation 0.4 | Year | |
| Changes in Bone Age From Baseline to One Year | 120 μg/kg BID (Twice Daily Dosing) | 1.2 | Standard Deviation 0.5 | Year | |
| Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year | Untreated | 64 | Standard Deviation 120 | Percent change |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Untreated | 25 | |
| Overall Study | STARTED | 40 μg/kg BID (Twice Daily Dosing) | 16 | |
| Overall Study | STARTED | 80 μg/kg BID (Twice Daily Dosing) | 44 | |
| Overall Study | STARTED | 120 μg/kg BID (Twice Daily Dosing) | 51 | |
| Overall Study | COMPLETED | Untreated | 23 | |
| Overall Study | COMPLETED | 40 μg/kg BID (Twice Daily Dosing) | 16 | |
| Overall Study | COMPLETED | 80 μg/kg BID (Twice Daily Dosing) | 40 | |
| Overall Study | COMPLETED | 120 μg/kg BID (Twice Daily Dosing) | 45 | |
| Overall Study | NOT COMPLETED | Untreated | 2 | |
| Overall Study | NOT COMPLETED | 40 μg/kg BID (Twice Daily Dosing) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Untreated | 4 | 25 | 9 |
| other | Headache | Nervous system disorders | 40 μg/kg BID (Twice Daily Dosing) | 8 | 16 | 16 |
| other | Headache | Nervous system disorders | 80 μg/kg BID (Twice Daily Dosing) | 13 | 44 | 30 |
| other | Headache | Nervous system disorders | 120 μg/kg BID (Twice Daily Dosing) | 21 | 51 | 35 |
| other | Upper respiratory tract infection | Infections and infestations | Untreated | 6 | 25 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | 40 μg/kg BID (Twice Daily Dosing) | 3 | 16 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | 80 μg/kg BID (Twice Daily Dosing) | 10 | 44 | 17 |
| other | Upper respiratory tract infection | Infections and infestations | 120 μg/kg BID (Twice Daily Dosing) | 12 | 51 | 13 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Untreated | 4 | 25 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 40 μg/kg BID (Twice Daily Dosing) | 4 | 16 | 6 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Untreated | ||
| Total, all-cause mortality | 40 μg/kg BID (Twice Daily Dosing) | ||
| Total, all-cause mortality | 80 μg/kg BID (Twice Daily Dosing) | ||
| Total, all-cause mortality | 120 μg/kg BID (Twice Daily Dosing) | ||
| Total, other adverse events | Untreated | 18 | 25 |
| Total, other adverse events | 40 μg/kg BID (Twice Daily Dosing) | 16 | 16 |
| Total, other adverse events | 80 μg/kg BID (Twice Daily Dosing) | 37 | 44 |
| Total, other adverse events | 120 μg/kg BID (Twice Daily Dosing) | 43 | 51 |
| Total, serious adverse events | Untreated | 1 | 25 |
| Total, serious adverse events | 40 μg/kg BID (Twice Daily Dosing) | 1 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00125164
GET https://conductscience.org/api/trials/v1/NCT00125164/results?page=2