A Phase 3, Open-Label, 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
Study of Weekly MOD-4023 Compared to Daily Genotropin Therapy In Pre-Pubertal Children With Growth Hormone Deficiency
Sponsor: OPKO Biologics Ltd.
Enrolling: Male and Female Patients
Study Length: 12 Months
IRB Number: AAAR4415
U.S. Govt. ID: NCT02968004
Contact: Ilene Fennoy MD: 212- 305 -6559 / if1@cumc.columbia.edu
Additional Study Information: Your child has been asked to participate in this study because he/she may have or has growth hormone deficiency (i.e. not enough growth hormone in his/her body) and your doctor has already determined that your child may be suitable to be screened for this study. OPKO Biologics Ltd., the Sponsor of this clinical study, has developed an investigational drug called MOD-4023, a synthetic growth hormone, to replace the lack of growth hormone in your childs body. 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.
This study is closed
Ilene Fennoy, MD
Do You Qualify?
Is your daugther between 3 years of age and under age of 11? Is your son between 3 years of age and under 12 years of age? Yes No
Does your child have or may have growth hormone deficiency? Yes No
Has your child received previous treatment with rhGH? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Ilene Fennoy MD
212- 305 -6559