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Completed

NCT Number: NCT00184717

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

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.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

0.033 mg/kg/day of NN-220 for s.c. injection in cartridge

Primary outcomes

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

    Time frame: 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

  2. 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

    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 outcomes

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

    Time frame: Weeks 0-260

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

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

    Time frame: Weeks 0-208

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

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

    Time frame: 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, ….

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

    Time frame: 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, ….

  5. Adverse Events - Subjects Received NN220 Treatment for 5 Years

    Time frame: 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

  6. Adverse Events - Subjects Received NN220 Treatment for 4 Years

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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