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Completed

NCT Number: NCT00537914

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

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Key information

Conditions

Small for Gestational Age

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sandoz Investigational Site, Edegem, Antwerpen, Belgium

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About this study

Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
  • Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
  • Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion criteria

  • Onset of puberty
  • Closed epiphyses
  • Diabetes mellitus type I or type II
  • Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
  • Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
  • Known IGF-I level above +2SD for sex and age
  • Acute critical illness
  • Previous treatment with any hGH preparation
  • Treatment with antidiabetic medication (e.g. metformin, insulin)
  • Drug abuse, substance abuse, or alcohol abuse

Treatment and study plan

Omnitrope

Drug

All enrolled patients received Omnitrope. The median daily dose varied between 0.0340 and 0.0351 mg/kg/day and the maximum range was 0.000 to 0.040 mg/kg/day over all visits.

Other names: Somatropin

Primary outcomes

  1. Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment

    Time frame: throughout the study, approximately 13 years

    The development of diabetes in short children born SGA during treatment was evaluated based on the carbohydrate metabolism parameters FPG, HbA1c and OGTT (basal and 2-h plasma glucose). Only cases which were confirmed by the investigator were included.

Secondary outcomes

  1. Mean Change in Height (H) (cm) From Baseline

    Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

    Mean change in Height from baseline for all patients was reported.

  2. Mean Change in Height Standard Deviation Score Over Time From Baseline

    Time frame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years

    SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table.

    In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the catch-up growth over time towards average normal growth starting from below average.

  3. Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline

    Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

    Mean change in Height velocity (HV) (cm/year) over time from baseline was reported.

  4. Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline

    Time frame: Baseline, 3 months, 0.5 year, 9 months, 1 year, 1.25 years, 1.5 years, 1.75 years, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, 11 years, 12 years, 12.5 years

    SDS reflects the deviation of a measured value from the mean value of normally growing children of the same sex and chronological age, expressed in units of the standard deviation (SD) of normally growing children of the same sex and chronological age. SDS was calculated according to the formula SDS=(X1-X2)/SD, where X1 is the measured value, X2 the mean value for the relevant chronological age and sex, and SD the reference standard deviation for the relevant sex and age. Refer to SAP page 14 for the formula and to Appendix B (H SDS) and D (HV SDS) for the applied reference Table.

    In general, a negative SDS indicates that the value is below average or mean and a positive value means it is above the average or mean. The calculated mean change compared to baseline reflects the initial high increase in height velocity which remains positive over years, but is decreasing over time.

  5. Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline

    Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

    Mean change in serum IGF-1 level (nmol/L) from baseline was reported.

  6. Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline

    Time frame: Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

    Mean change in IGFBP-3 levels (nmol/L) from baseline was reported.

  7. Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment

    Time frame: throughout the study, approximately 13 years

    Number of participants with the development of anti-rhGH antibodies with positive test result were reported.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Important dates

Study start
2008
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2007
Registry last updated
Mar 12, 2024

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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