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CP-4-006 study


Title A Phase 3, Open-labeled, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly Mod-4023 Compared to Daily Genotropin© Therapy in Pre-pubertal Children with Growth Hormone Deficiency 
Therapeutic Area Growth problems (Floating)
Principal Investigator Robert Gensure, MD, PhD
Min Age 3 Years
Max Age 11 Years
Gender Any
Contact Vidya Iyer
617-636-0186
More Information https://www.clinicaltrials.gov/ct2/show/NCT02968004

Overview

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. 

Study Details

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