Saizen in Intra-uterine Growth Retardatio

• Conditions: Children Born With Serious Intra-uterine Growth Retardation; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2015-001708-69-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: 91

Inclusion Criteria

•Previous inclusion, good compliance and normal completion of GF4001 or GF6283 in the treatment of growth failure in children born with serious IUGR (3-year continuous r-hGH treatment in GF4001 or 2-year continuous or intermittent r-hGH treatment in GF6283).
•Increase in height greater than 0.5 standard deviation (SD) during the first 2 years of r-hGH treatment in GF4001 or after 2 years of continuous or intermittent r-hGH treatment in GF6283.
•A written Informed Consent at the beginning of the pre-study visit must be obtained from the parent(s)/legal guardian(s), with the understanding that consent may be withdrawn by the subject or parents at any time without prejudice to their future medical care. Children able to understand the trial should personally sign and date the written informed consent, too.
•Other protocol-defined inclusion criteria may apply.

Are the trial subjects under 18? yes
Number of subjects for this age range: 91
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

•Known multiple malformation syndrome with severe psychomotor retardation and/or body hemihypertrophy.
•Severe psychomotor retardation.
•Severe congenital malformations.
•Other protocol-defined exclusion criteria may apply.

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 was to follow children born with serious IUGR, and treated with 1.4 IU/kg/week (0.47 mg/kg/week) of Saizen according to various therapeutic schedules, until they reach final height while assessing both efficacy and safety (studies A, B and C).<br><br>;Secondary Objective: -To compare the effect on final height of continuous versus intermittent long term r-hGH administration (study A)<br>- To study the efficacy and safety of r-hGH therapy during puberty in children born with serious IUGR (study B) as well as the effect of r-hGH on the timing and tempo of puberty in this population<br>- To assess the effect of the schedule and duration of the initial Saizen treatment (during studies 4001 and 6283) on final height (study C).;Primary end point(s): Final Height <br>Height Standard Deviation Score (HSDS) ;Timepoint(s) of evaluation of this end point: One year after final height was attained up to 10.6 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Parental Adjusted Height Standard Deviation Score (PAHSDS);Timepoint(s) of evaluation of this end point: One year after final height was attained up to 10.6 years