Overview

Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

Status:
Completed
Trial end date:
2020-03-06
Target enrollment:
Participant gender:
Summary
Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Secondary • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.
Phase:
Phase 3
Details
Lead Sponsor:
OPKO Health, Inc.
Treatments:
Hormones