Trial · NCT00571727

Long-Term Treatment With rhIGF-1 in GHIS

NCT00571727, Phase 2, Phase 3, Completed, Ipsen; results first posted 2023-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Treatment With rhIGF-1 in GHIS. Trials, record NCT00571727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00571727

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Trial

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

Title: Long-Term Treatment With rhIGF-1 in GHIS
NCT number: NCT00571727
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 92 participants, actual
Lead sponsor: Ipsen
Conditions: Growth Hormone Insensitivity Syndrome
Interventions: mecasermin
First posted: 2007-12-12
Last updated: 2023-07-06
Results first posted: 2023-07-06

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Annualized Height Velocity Up to 12 Years	Baseline (Pre-dose) and up to 12 years	Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Primary	Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment	Baseline (Pre-dose) and 1 year	Height measurements were performed using wall-mounted stadiometers for analysis of growth data.
Secondary	Height Velocity Standard Deviation Score Up to 12 Years	Baseline (Pre-dose) and up to 12 years	Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height velocity-standard deviation score was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference mean height velocity. Greater height velocity standard deviation score indicates better outcome.
Secondary	Height Standard Deviation Score Up to 12 Years	Baseline (Pre-dose) and up to 12 years	Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height standard deviation score was calculated as height minus reference mean height divided by standard deviation of the reference mean height. A higher height standard deviation score indicates a better outcome.
Secondary	Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height	Baseline (Pre-dose) and up to 19 years	Height measurements were performed using wall-mounted stadiometers for analysis of growth data.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annualized Height Velocity Up to 12 Years	Baseline (Pre-dose) and up to 12 years	The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous recombinant human insulin-like growth factor-1 (rhIGF-1) and whose pre-treatment height velocity were available were reported.	centimeter per year (cm/y)	MEAN
PRIMARY	Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment	Baseline (Pre-dose) and 1 year	The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 were reported.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Height Velocity Standard Deviation Score Up to 12 Years	Baseline (Pre-dose) and up to 12 years	The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 and whose pre-treatment height velocity were available were reported.	Standard deviation score	MEAN
SECONDARY	Height Standard Deviation Score Up to 12 Years	Baseline (Pre-dose) and up to 12 years	The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 were reported.	Standard deviation score	MEAN
SECONDARY	Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height	Baseline (Pre-dose) and up to 19 years	The intention-to-treat population consisted of all 92 participants. Only data from the participants naïve to exogenous rhIGF-1 and who attained near adult height were reported.	cm	MEAN

Source ClinicalTrials.gov

Results by group41

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

Outcome	Group	Category	Value	Spread	Units
Annualized Height Velocity Up to 12 Years	Mecasermin	Baseline (Pre-dose)	2.6	Standard Deviation 1.7	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 1 year	8.0	Standard Deviation 2.3	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 2 years	5.9	Standard Deviation 1.7	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 3 years	5.5	Standard Deviation 1.8	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 4 years	5.2	Standard Deviation 1.5	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 5 years	4.9	Standard Deviation 1.5	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 6 years	4.8	Standard Deviation 1.4	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 7 years	4.3	Standard Deviation 1.5	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 8 years	4.4	Standard Deviation 1.5	centimeter per year (cm/y)
Annualized Height Velocity Up to 12 Years	Mecasermin	>= 9 years	4.4	Standard Deviation 1.7	centimeter per year (cm/y)

1 to 10 of 41Source ClinicalTrials.gov

See all 41 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Mecasermin	92
Overall Study	COMPLETED	Mecasermin	26
Overall Study	NOT COMPLETED	Mecasermin	66

Source ClinicalTrials.gov

Adverse events73

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	Hypoglycaemia	Metabolism and nutrition disorders	Mecasermin	41	92	175
other	Hypoglycaemic seizure	Metabolism and nutrition disorders	Mecasermin	5	92	13
other	Injection site hypertrophy	General disorders	Mecasermin	32	92	211
other	Pyrexia	General disorders	Mecasermin	19	92	77
other	Fatigue	General disorders	Mecasermin	9	92	16
other	Injection site haematoma	General disorders	Mecasermin	9	92	22
other	Hypertrophy	General disorders	Mecasermin	8	92	52
other	Asthenia	General disorders	Mecasermin	5	92	7
other	Chest pain	General disorders	Mecasermin	5	92	10
other	Upper respiratory tract infection	Infections and infestations	Mecasermin	23	92	73

1 to 10 of 73Source ClinicalTrials.gov

See all 73 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mecasermin	0	92
Total, other adverse events	Mecasermin	73	92
Total, serious adverse events	Mecasermin	18	92

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
17192294	RESULT

Source PubMed

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.

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