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

Sandoz

Status and phase: Completed; Phase 4

Conditions: Small for Gestational Age

Treatments: Drug: Omnitrope

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537914

CEP00-401

2006-002506-58 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 278 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 1 patient group

Omnitrope

Experimental group

Description:

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.

Treatment:

Drug: Omnitrope