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To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
Sponsor: Febico Biomedical Corp.
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)
Official title: A Phase I/II Randomized, Double-blinded Study of FB-1603 to Evaluate the Safety and Efficacy in Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization (FECHT Trial)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-06-24
Completion Date
2027-08-06
Last Updated
2025-02-27
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo oral capsule
FB-1603
FB-1603 (165 mg/cap) oral capsule
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan, Taiwan