Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

Novo Nordisk A/S98 enrolled

Overview

This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years). Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Foetal Growth Problem Small for Gestational Age

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * For MAIN period (GHLIQUID-1516): * Born small for gestational age (SGA) with birth weight and birth length below the 10th percentile for gestational age, and additional either birth length below or equal to -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for gestational age * Growth failure with height at -2.0 SDS or below for chronological age (CA) * Normal growth hormone (GH) production, defined as peak GH level \> 10 ng/mL in one GH provocation test * For EXTENSION period (GHLIQUID-1517): * Subjects who completed the main period * Chronological age (CA) for boys at least 4 years, but maximum 11 years * Chronological age (CA) for girls at least 4 years, but maximum 10 years Exclusion Criteria: * Subjects with diabetes mellitus * Subjects suffering from malignancy * Several medical conditions

Outcomes

Primary Outcomes

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years

Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit

Time frame: Week 0, week 260

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years

Time frame: Week 0, week 208

Secondary Outcomes

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years

Yearly Height velocity SDS for chronological age were summarised and graphically presented

Time frame: Weeks 0-260

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years

Yearly Height velocity SDS for chronological age were summarised and graphically presented

Time frame: Weeks 0-208

Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years

Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….

Time frame: Week 0, week 260

Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years

Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….

Time frame: Week 0, week 208

Adverse Events - Subjects Received NN220 Treatment for 5 Years

Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly

Time frame: Weeks 0-260

Adverse Events - Subjects Received NN220 Treatment for 4 Years

Time frame: Weeks 0-208

Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes