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

Phase 3

Completed

• Conditions: Foetal Growth Problem; Small for Gestational Age
• Interventions: Drug: somatropin

• Registration Number: NCT00184717
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-18
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-03-29
• Study Completion: 2009-12-28
• Results First Submitted: 2010-12-22
• Results First Submitted QC: 2011-06-29
• Results First Posted: 2011-07-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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Exclusion Criteria

• Subjects with diabetes mellitus
• Subjects suffering from malignancy
• Several medical conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No treatment --> 0.033 mg	somatropin	In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
0.033 mg / NN-220	somatropin	In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
0.067 mg / NN-220	somatropin	In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
No treatment --> 0.067 mg	somatropin	In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Primary Outcome Measures

Name	Time	Method
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years	Week 0, week 208	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
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years	Week 0, week 260	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

Secondary Outcome Measures

Name	Time	Method
Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years	Week 0, week 208	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, ....
Adverse Events - Subjects Received NN220 Treatment for 4 Years	Weeks 0-208	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
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years	Weeks 0-260	Yearly Height velocity SDS for chronological age were summarised and graphically presented
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years	Weeks 0-208	Yearly Height velocity SDS for chronological age were summarised and graphically presented
Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years	Week 0, week 260	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, ....
Adverse Events - Subjects Received NN220 Treatment for 5 Years	Weeks 0-260	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan