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

• Status: Active, not recruiting
• Trial end date: 2022-01-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz

Criteria

Inclusion Criteria:

1. Pre-pubertal (Tanner stage I) children born SGA

• Boys: 4 years of age or older

• Girls: 4 years of age or older

2. Growth disturbance for chronological age and sex according to country specific references

3. Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria:

1. Onset of puberty

2. Closed epiphyses

3. Diabetes mellitus type I or type II

4. Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample

5. 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

6. Acute critical illness

7. Previous treatment with any hGH preparation

8. Treatment with antidiabetic medication (e.g. metformin, insulin)

9. Drug abuse, substance abuse, or alcohol abuse