Overview

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)

Status:
Terminated
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Serono S.P.A., Italy
Treatments:
Hormones
Criteria
Inclusion Criteria:

- SGA at birth (defined as a length at birth equal or below the tenth percentile
according to the Italian reference table of Bertini and Fabris)

- Age of 24 Months

- Caucasic

- Born at term (i.e. after the 37th completed week of gestation)

- Height equal or below (Group A) or up (Group B) the third percentile at the age of 24
months according to the Tanner reference table

- Sufficient GH secretion (more than 10 nanogram (ng)/milliliter (ml)) at least to one
of the tests commonly used at that age (glucagon, Levo-dopa, arginine, clonidine,
Growth Hormone Releasing Hormone (GHRH), GH integrated secretion)

- Normal level of Thyroid-stimulating hormone (THS), Free Triiodothyronine (FT3), Free
Thyroxine (FT4), Insulin-like growth factor 1(IGF-1), insulin and haemoglobin A1c
(HbA1c)

- Normal level of Immunoglobulin A (IgA)

- Children parents willing to comply with the protocol for the whole duration of the
study

- A written Informed Consent before the baseline visit must be obtained from the
parent(s) / legal guardian(s)

Exclusion Criteria:

- Congenital malformations (including Silver-Russel syndrome)

- Known abnormal karyotype, especially in girls

- Twins

- Severe psychomotor retardation

- Previous or ongoing treatment with anabolic steroids or r-hGH

- Treatments interfering with the immune system (including bacterial lysate)

- Severe chronic illnesses

- Autoimmune diseases