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RECRUITING
NCT06478719
PHASE1/PHASE2

To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization

Sponsor: Febico Biomedical Corp.

View on ClinicalTrials.gov

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

Interventions

DRUG

Placebo

Placebo oral capsule

DRUG

FB-1603

FB-1603 (165 mg/cap) oral capsule

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan