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A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)

2014-08-27 03:15:56 | BioPortfolio

Summary

This open, multicentric, randomised, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.

Description

This open, multicentric, randomised, controlled study is planned to identify genes activated by hGH in SGA children responders to treatment (making it possible in the near future to better identify SGA children likely to benefit from hGH treatment). Furthermore, the study will hopefully allow to verify which genes are responsible of spontaneous catch-up growth in children with diagnosis of SGA at birth but above the 3th percentile for height at the age of 24 months, and if these genes are the same activated by hGH during the treatment in subjects responders. Sixty children born at term (i.e. after the 37th completed week of gestation) and with a diagnosis of SGA (defined as a length ≤ 10th percentile according to the Italian reference table published by Bertini and Fabris) will be enrolled in the study. Forty subjects (group A) were still ≤ 3rd percentile for height (according to the Tunner reference table) at the age of 24 months, the remaining 20 (group B) being ≥3rd percentile (thus showing a spontaneous catch-up growth). Group A will be randomized to receive Saizen at the daily dose of 0.067 mg/kg (Group A1) or no treatment (Group A2) for two years. All subjects will undergo full clinical examination and blood chemistry at baseline visit and visit after 1,6,12, 18 and 24 months for a period of two years. Gene expression analysis using the Clontech Atlas Human Array was performed in all subjects at baseline and after one year in order to identify the possible correlation between catch-up growth (either spontaneous or drug-induced) and expression of some genes.

OBJECTIVES

Primary objective:

- To evaluate the correlation between gene expression profiling and catch-up growth (either spontaneous or drug induced after one year of treatment) in SGA children.

Secondary Objectives:

- To evaluate the percentage of subjects not treated who show a spontaneous catch-up growth during the two years of observation.

- To assess the safety and tolerability of early treatment with Saizen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infant, Small for Gestational Age

Intervention

Recombinant human growth hormone (r-hGH)

Location

Merck Serono S.p.A.
Roma
Italy

Status

Terminated

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:56-0400

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