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

Small for Gestational Age Clinical Trial

Official title:

GHLIQUID-1516: A 104-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age / GHLIQUID-1517: A Long-term, Multi-centre, Randomised, Controlled, Double-blind, Parallel-group Trial, Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184717
• Other study ID #: GHLIQUID-1517
• Secondary ID: JapicCTI-050137J
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: March 23, 2015
• Start date: July 2003
• Est. completion date: December 2009

Study information

• Verified date: March 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00184704

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin
0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
• somatropin
0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
• somatropin
0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
• somatropin
0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 0, week 260	No
Primary	Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 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	Week 0, week 208	No
Secondary	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	Weeks 0-260	No
Secondary	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	Weeks 0-208	No
Secondary	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, ….	Week 0, week 260	No
Secondary	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, ….	Week 0, week 208	No
Secondary	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	Weeks 0-260	Yes
Secondary	Adverse Events - Subjects Received NN220 Treatment for 4 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	Weeks 0-208	Yes

External Links

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