drugset / Trial / NCT06478719
To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
Phase 1/2
Recruiting
120 enrolled
Febico Biomedical Corp.
National Taiwan University Hospital · collab
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The goal of this clinical trial is to assess the efficacy of FB-1603 on improving liver function impairment in hepatocellular carcinoma patients receiving transarterial chemoembolization. The main question it aims to answer is: Changes in the level of liver function parameters, including AST, ALT, or total bilirubin, from baseline to Visit 3, Visit 4, Visit 5, and Visit 6 There is a comparison group: Researchers will compare arm 1 placebo to see if FB-1603 is work to treat the liver function. Participants will 1. Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks. 2. Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)
Timeline
- Start
- 2024-06-24
- Primary completion
- 2028-06-07
- Completion
- 2028-08-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FB-1603 | Unknown | 990 mg | Oral |
| Subject | FB-1603 | Unknown | 1980 mg | Oral |