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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00537914 (opens ClinicalTrials.gov in a new tab)Other idCEP00-401Other id2006-002506-58
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
278 participants (actual)
Sponsor
Sandoz · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
7 countries

Belgium, Czechia, Georgia, Germany, Hungary, Poland, Romania

Start
6 Feb 2008
Primary completion
25 Mar 2022
Completion
25 Mar 2022
First posted
2 Oct 2007 (estimated)
Last update posted
12 Mar 2024
Conditions
Small for Gestational Age

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020152020
  1. Ph 4

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

    NCT00537914

    6 Feb 2008 to 25 Mar 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • OmnitropeDrug

Arms1

  • Experimental

    Omnitrope

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · throughout the study, approximately 13 years

    Registry description

    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(7)

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

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· throughout the study, approximately 13 years

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

GroupValue (Participants)
Omnitrope0
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

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

GroupValue (cm)
Omnitrope2.74
Secondary outcomeMean· 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

Mean Change in Height Standard Deviation Score Over Time From Baseline

GroupValue (SDS)
Omnitrope0.30
Secondary outcomeMean· Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

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

GroupValue (cm/year)
Omnitrope6.45
Secondary outcomeMean· 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

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

GroupValue (SDS)
Omnitrope8.41
Secondary outcomeMean· Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

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

GroupValue (nmol/L)
Omnitrope13.04
Secondary outcomeMean· Baseline, 3 months, 1 year, 2 years, 5 years and 9 years

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

GroupValue (nmol/L)
Omnitrope24.85
Secondary outcomeCount of participants· throughout the study, approximately 13 years

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

GroupValue (Participants)
Omnitrope23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OmnitropeAll 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.1 / 27774 / 277210 / 277

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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