drugset / Trial / NCT04633057

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency

NCT04633057 ↗

Phase 3 Completed 168 enrolled TJ Biopharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.

Timeline

Start
2021-01-25
Primary completion
2023-07-31
Completion
2023-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator NordiFlex Protein / enzyme biologic 0.034 mg/kg —
Subject TJ101 Protein / enzyme biologic 1.2 mg/kg —

Indications