Trial · NCT00125190

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

NCT00125190, Phase 2, Phase 3, Completed, Ipsen; results first posted 2010-04-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency. Trials, record NCT00125190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00125190

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
NCT number: NCT00125190
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 45 participants, actual
Lead sponsor: Ipsen
Conditions: Insulin-Like Growth Factor-1 Deficiency, Growth Disorders
Interventions: rhIGF-1 (mecasermin) for a period of 86 weeks
First posted: 2005-07-29
Last updated: 2020-07-27
Other registries' IDs: eudract:2019-001095-11
Results first posted: 2010-04-15

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Height Velocity From Pretreatment (Week 0) to Week 34	Pretreatment to Week 34	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.
Primary	Height Velocity From Week 34 to 86	Week 34 to 86	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	Change in Height SD Score From Pretreatment to Week 34	Pretreatment and Week 34	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.
Secondary	Change in Height SD Score From Pretreatment to Week 86	Pretreatment and Week 86	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.
Secondary	Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age	Pretreatment to Week 86	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.
Secondary	Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	Pretreatment and Week 86	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.
Secondary	Percent Change in Serum Concentration of ALS From Pretreatment to Week 86	Pretreatment and Week 86	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Height Velocity From Pretreatment (Week 0) to Week 34	Pretreatment to Week 34	The ITT population included all treated subjects.	centimeters per year (cm/yr)	MEAN
PRIMARY	Height Velocity From Week 34 to 86	Week 34 to 86	The ITT population included all treated subjects. Only subjects in the ITT population who continued past Week 34 were included in the analysis.	cm/yr	MEAN
SECONDARY	Change in Height SD Score From Pretreatment to Week 34	Pretreatment and Week 34	The ITT population included all treated subjects.	SDs	MEAN
SECONDARY	Change in Height SD Score From Pretreatment to Week 86	Pretreatment and Week 86	The ITT population included all treated subjects. Only subjects who had both pretreatment and Week 86 measurements were included in the analysis.	SDs	MEAN
SECONDARY	Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age	Pretreatment to Week 86	The ITT population included all treated subjects. Only subjects who had both pretreatment and Week 86 measurements were included in the analysis.	years	MEAN
SECONDARY	Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	Pretreatment and Week 86	The ITT population included all treated subjects. Only subjects who had both pretreatment and Week 86 measurements were included in the analysis.	percent change	MEDIAN
SECONDARY	Percent Change in Serum Concentration of ALS From Pretreatment to Week 86	Pretreatment and Week 86	The ITT population included all treated subjects. Only subjects who had both pretreatment and Week 86 measurements were included in the analysis.	percent change	MEDIAN
POST_HOC	Increase in Height Velocity From Pretreatment to Week 34	Pretreatment to Week 34	Completer population included all subjects who remained on study to Week 86. Subjects who completed Week 34 were included in the analysis.	cm/yr	MEAN
POST_HOC	Increase in Height Velocity From Pretreatment to Week 86	Pretreatment to Week 86	Completer population included all subjects who remained on study to Week 86.	cm/yr	MEAN

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Height Velocity From Pretreatment (Week 0) to Week 34	rhIGF-1 QD		7.0	Standard Deviation 1.5	centimeters per year (cm/yr)
Height Velocity From Week 34 to 86	rhIGF-1 QD		6.7	Standard Deviation 1.8	cm/yr
Change in Height SD Score From Pretreatment to Week 34	rhIGF-1 QD		0.21	Standard Deviation 0.20	SDs
Change in Height SD Score From Pretreatment to Week 86	rhIGF-1 QD		0.45	Standard Deviation 0.39	SDs
Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age	rhIGF-1 QD		0.2	Standard Deviation 0.68	years
Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	rhIGF-1 QD	IGFBP-1	-89.6	Inter-Quartile Range -96 to -13	percent change
Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	rhIGF-1 QD	IGFBP-2	37.9	Inter-Quartile Range -25 to 227	percent change
Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	rhIGF-1 QD	IGFBP-3	0	Inter-Quartile Range -27 to 48	percent change
Percent Change in Serum Concentration of ALS From Pretreatment to Week 86	rhIGF-1 QD		-7.7	Inter-Quartile Range -36 to 42	percent change
Increase in Height Velocity From Pretreatment to Week 34	rhIGF-1 QD		1.3	Standard Deviation 3.56	cm/yr

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	rhIGF-1 QD	45
Overall Study	Completed 34 Weeks of Study	rhIGF-1 QD	43
Overall Study	COMPLETED	rhIGF-1 QD	30
Overall Study	NOT COMPLETED	rhIGF-1 QD	15

Source ClinicalTrials.gov

Adverse events27

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	Abdominal Pain	Gastrointestinal disorders	rhIGF-1 QD	3	45	3
other	Abdominal Pain Upper	Gastrointestinal disorders	rhIGF-1 QD	3	45	4
other	Diarrhoea	Gastrointestinal disorders	rhIGF-1 QD	5	45	6
other	Stomach Discomfort	Gastrointestinal disorders	rhIGF-1 QD	3	45	3
other	Vomiting	Gastrointestinal disorders	rhIGF-1 QD	18	45	21
other	Injection Site Bruising	General disorders	rhIGF-1 QD	3	45	5
other	Pyrexia	General disorders	rhIGF-1 QD	14	45	18
other	Gastroenteritis	Infections and infestations	rhIGF-1 QD	6	45	8
other	Gastroenteritis Viral	Infections and infestations	rhIGF-1 QD	3	45	4
other	Influenza	Infections and infestations	rhIGF-1 QD	5	45	6

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	rhIGF-1 QD	0	45
Total, other adverse events	rhIGF-1 QD	41	45
Total, serious adverse events	rhIGF-1 QD	2	45

Source ClinicalTrials.gov

Papers0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00125190

GET https://conductscience.org/api/trials/v1/NCT00125190/events?page=2

API reference For AI assistants