U.S., April 29 -- ClinicalTrials.gov registry received information related to the study (NCT07553351) titled 'GB06 Phase III Trial for Pediatric Growth Hormone Deficiency' on April 20.
Brief Summary: This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin(R)FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin(R)FlexProTM. To achieve this, the participants will administer GB06 or Norditropin(R)FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.
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