drugset / Trial / NCT07691125

Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome

NCT07691125

Phase 4 Recruiting 100 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, single-arm clinical trial. A total of 100 participants with short bowel syndrome (SBS) receiving parenteral nutrition (PN) support are planned to be enrolled. The trial includes a 2-week run-in phase and a 4-week intervention phase, during which participants will receive rhGH injections. A safety follow-up period will then be conducted through Week 52.

Timeline

Start
2024-07-31
Primary completion
2027-04-28
Completion
2028-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic Other

Indications