Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Long-Term Treatment With rhIGF-1 in GHIS

NCTNCT00571727Other idStudy 1419

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 92 participants (actual)
Sponsor: Ipsen · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 20 May 1991
Primary completion: 15 Dec 2011
Completion: 15 Dec 2011
First posted: 12 Dec 2007 (estimated)
Last update posted: 6 Jul 2023
Conditions: Growth Hormone Insensitivity Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

1995200020052010

Ph 2/3
Long-Term Treatment With rhIGF-1 in GHIS
NCT00571727
20 May 1991 to 15 Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Interventions

mecaserminDrug

Arms1

Experimental
mecasermin, injections BID of rhIGF-1

Primary outcomes2

Outcomes the sponsor listed as primary.

Annualized Height Velocity Up to 12 Years
Time frame · Baseline (Pre-dose) and up to 12 years
Registry description
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment
Time frame · Baseline (Pre-dose) and 1 year
Registry description
Height measurements were performed using wall-mounted stadiometers for analysis of growth data.

Secondary outcomes(3)

Height Velocity Standard Deviation Score Up to 12 Years
Time frame · Baseline (Pre-dose) and up to 12 years
Registry description
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.
Height Standard Deviation Score Up to 12 Years
Time frame · Baseline (Pre-dose) and up to 12 years
Registry description
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.
Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height
Time frame · Baseline (Pre-dose) and up to 19 years
Registry description
Height measurements were performed using wall-mounted stadiometers for analysis of growth data.

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· Baseline (Pre-dose) and up to 12 years

Annualized Height Velocity Up to 12 Years

Group	Value (centimeter per year (cm/y))	Spread
Mecasermin	2.6	1.7

Primary outcomeCount of participants· Baseline (Pre-dose) and 1 year

Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment

Group	Value (Participants)
Mecasermin	7

Secondary and other outcome results(3)

Secondary outcomeMean· Baseline (Pre-dose) and up to 12 years

Height Velocity Standard Deviation Score Up to 12 Years

Group	Value (Standard deviation score)	Spread
Mecasermin	-3.4	1.6

Secondary outcomeMean· Baseline (Pre-dose) and up to 12 years

Height Standard Deviation Score Up to 12 Years

Group	Value (Standard deviation score)	Spread
Mecasermin	-6.9	1.8

Secondary outcomeMean· Baseline (Pre-dose) and up to 19 years

Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height

Group	Value (cm)	Spread
Mecasermin	13.3	8.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
MecaserminParticipants who were entered from previous studies continued to receive mecasermin 80 to 120 mcg/kg SC twice daily and naïve-to-treatment participants were administered mecasermin 60 to 80 mcg/kg SC twice daily for 1 to 2 weeks, and then increased to 120 mcg/kg as tolerated.	0 / 92	18 / 92	73 / 92

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2007

5 results

Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity.

Chernausek et al. 2007The Journal of clinical endocrinology and metabolismcited by 152

PMID 17192294DOI 10.1210/jc.2006-1610PUB-17192294

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 2 Years up to 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Height \<-2SD for age and gender * IGF-1 \<-2SD for age and gender * Evidence of GH resistance Exclusion Criteria: * closed epiphyses * prior active malignancy * major organ disfunction * treatment with medications that would diminish growth * clinically significant cardiac abnormalities

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