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Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF) | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

Predictive Value of Baseline and Stimulated Serum IGF-1 and IGFBP-3 During a Dose-escalation IGF-1 Generation Test for the 1 Year Growth Response to Growth Hormone (GH) Therapy in Short Children With Low IGF-1 and a Normal GH Peak in a Provocation Test

NCT01438801•Ipsen

View on ClinicalTrials.gov

Summary

The evaluation of a standardized diagnostic test to predict the growth response in a 1 year trial with Growth Hormone (GH) treatment (carried out in the context of regular patient care) in non GH deficient short children with low serum insulin-like growth factor-1 (IGF-1).

Eligibility

Age

2 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 2.0 - 9.0 years for females, 2.0 - 10.0 yrs for males.
•Prepubertal stage (Tanner 1 for breast (B1) in females, or Tanner 1 for genitals (G1) for males).
•Bone age \< 10 'years' (males) or \< 9 'years' (females) according to Greulich and Pyle. The bone age will be read by the pediatric endocrinologist responsible for the pre-study screening visit.
•Height SDS \< -2.5 for ethnically adequate references. For children of Dutch or Western European origin the 1997 nation-wide references for Dutch children will be used. For children of Moroccan or Turkish origin, the respective reference charts will be used. For children of other ethnicities, the 1977 North American (NCHS/WHO) reference will be used, as these charts have been accepted by WHO as world-wide standard from the age of 5 years.

Exclusion Criteria

•Has a history of hypersensitivity to growth hormone or phenol (conservative added to GH in NutropinAq), or drugs with a similar chemical structure.
•Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
•Has a birth weight and/or length below -2 SDS for Swedish reference charts. Patients will not be excluded due to an unknown birth weight or length.
•Has a known cause of short stature, or any significant concomitant disease that is likely to interfere with growth or with the study schedule/objectives, or is a known contraindication to GH treatment.

Key Dates

Start Date

May 1, 2013

Primary Completion Date

May 31, 2013

Completion Date

May 31, 2013

Last Updated

August 5, 2019

Conditions

Idiopathic Short Stature

Interventions

Nutropin [Somatropin (rDNA origin) for injection]

DRUG

A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

NCT05894876

Idiopathic Short Stature

View study

COMPLETED

Skeletal Muscle Effects of GH in Boys

NCT04020913

Growth Hormone DeficiencyIdiopathic Short Stature

View study

COMPLETEDPHASE3

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.