drugset / Trial / NCT07544121
Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
Not yet recruiting
1034 enrolled
Nanfang Hospital, Southern Medical University
Beijing 302 Hospital · collabBeijing Ditan Hospital · collabShenzhen Third People's Hospital · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2028-04-01
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Babao Dan Capsule | Unknown | 0.6 g | — |