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

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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

Brief description of study

The purpose of this study is to compare the effectiveness, safety and handling of the investigational drug MOD-4023 (weekly injections, initial 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. OPKO Biologics Ltd., the Sponsor of this clinical study, has developed an investigational drug called MOD-4023, a synthetic GH, to replace the lack of Growth Hormone (GH) in the child’s body. “Investigational” means that the study drug is currently being tested. It is not approved for marketing by any regulatory authority. Girls between 3 years of age and under the age of 11 and boys 3 years of age and under the age of 12 with Growth Hormone Deficiency (GHD) are suitable to take part in this study. All participants need to have a screening visit to make sure they are eligible for this study.

Clinical Study Identifier: s18-01253

ClinicalTrials.gov Identifier: NCT02968004

Principal Investigator: Paul Saenger.

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