drugset / Trial / NCT03309891
Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open-label, active controlled, Phase 2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and semi-monthly doses of GX-H9 in the treatment of Paediatric Growth Hormone Deficiency (PGHD) as compared to the standard of care daily rhGH treatment.
Timeline
- Start
- 2016-01-18
- Primary completion
- 2017-10-27
- Completion
- 2019-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GX-H9 | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | — | Subcutaneous |