drugset / Trial / NCT05996393

CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly

NCT05996393

Phase 4 Completed 86 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, prospective, randonmized study. Our previous retrospective study showed that for SAA patients who were intolerant to ATG, CsA+ eltrombopag (EPAG) had similar efficacy to CsA+ATG+EPAG. Since the action mechanism of AVA and EPAG is not exactly the same, and the metabolic level of the elderly is not the same as that of younger patients, it is unknown whether there are predictive factors of efficacy in the treatment of AVA. We wondered whether CsA+AVA could achieve an efficacy similar to CsA+ATG+AVA in the Elderly. Meanwhile, to explore the predictive factors of efficacy, to find out a safe and effective treatment strategy for the Elderly.

Timeline

Start
2023-09-15
Primary completion
2025-02-20
Completion
2025-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Anti-Human Thymocyte Immunoglobulin, Rabbit Unknown 3 mg/kg
Background Avatrombopag Small molecule 60 mg Oral
Background Cyclosporine Peptide 3 mg/kg Oral
Background Cyclosporine Peptide 5 mg/kg Oral

Indications