The purpose of this study is to compare the effectiveness, safety and handling of the investigational drug MOD-4023 (weekly injections, dose of 0.66 mg/kg/week) to standard of care treatment with Genotropin (daily injections, dose of 0.034 mg/kg/day over one year. The study will include approximately 220 children worldwide.
Inclusion Criteria
- Confirmed diagnosis of GHD
- Bone age is not older than chronological age (Less than 10 for girls and less than 11 for boys)
- No prior exposure to any r-hGH therapy
Exclusion Criteria
- Children with prior history of leukemia, lymphoma, sarcoma, or any other cancer.
- History of radiation therapy or chemotherapy
- Children born small for gestational age (SGA - birth weigh and or birth length < 2 SDS for gestational age)
Study Requirements
The study takes place during a period of up to 14 months in total. The subject will have 7-11 scheduled visits to the clinical (depending on the treatment he/she will receive)
- ECG will be performed twice
- X-ray of hands for bone age will be done three times
- MRI with contrast dye will be performed only if the subject has not had one in the last six months
- Urine sample will be collected seven times
- Blood draws for lab testing will be collected seven times. The screening visit will be about 5 teaspoons of blood (approximately 23mL) and all other draws will be approximately 4 teaspoons of blood (approximately 20mL)
- A physical exam will be performed at each office visit
