Previous Study | Return to List | Next Study 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) (SAIZEN in SGA)

• Conditions: Small for Gestational Age; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2015-001681-25-Outside-EU/EEA
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 25

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study was to evaluate the correlation between gene expression and catch-up growth (either spontaneous or drug-induced after one year of treatment) in SGA children.;Secondary Objective: A secondary objective was to evaluate the percentage of patients who were not treated, but who showed a spontaneous catch-up growth during two years of observation.<br><br>Safety objectives included the safety and tolerability of Saizen (recombinant human growth hormone, r-hGH) in SGA children.;Primary end point(s): Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children;Timepoint(s) of evaluation of this end point: Baseline and Week 48

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth<br>Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation;Timepoint(s) of evaluation of this end point: Baseline through Week 96