Phase 4
N=278
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Small for Gestational Age
Bottom Line
View on ClinicalTrials.gov: NCT00537914 ↗Enrolled (actual)
278
Serious AEs
26.7%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omnitrope (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Sandoz
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Development of Diabetes in Short Children Born SGA During Treatment |
— | — |
| SECONDARY Mean Change in Height (H) (cm) From Baseline |
2.74; 9.08; 16.52; 35.10; 58.07 | — |
| SECONDARY Mean Change in Height Standard Deviation Score Over Time From Baseline |
0.30; 0.51; 0.68; 0.81; 0.93; 1.04 | — |
| SECONDARY Mean Change in Height Velocity (HV) (cm/Year) Over Time From Baseline |
6.45; 4.71; 3.02; 1.37; 0.10 | — |
| SECONDARY Mean Change in Height Velocity Standard Deviation Score (HV SDS) Over Time From Baseline |
8.41; 7.27; 6.69; 6.26; 5.29; 4.85 | — |
| SECONDARY Mean Change in Serum IGF-1 Level (Nmol/L) From Baseline |
13.04; 20.58; 30.64; 44.87; 75.72 | — |
| SECONDARY Mean Change in IGFBP-3 Levels (Nmol/L) From Baseline |
24.85; 30.48; 48.48; 92.94; 139.12 | — |
| SECONDARY Number of Participants With the Development of Anti-rhGH Antibodies During Omnitrope Treatment |
23 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00537914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.