drugset / Trial / NCT07002827
Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.
RandomizedParallel-groupOpen-labelTreatment
Summary
Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .
Timeline
- Start
- 2025-06-04
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 40 ug | Subcutaneous |
| Subject | G-CSF | Unknown | 5 ug/kg | Subcutaneous |
| Background | Albumin | Protein / enzyme biologic | — | — |
| Background | Lactulose | Other / unclassified | — | — |