To Evaluate Safety and Efficacy of FB-1603 in Hepatocellular Carcinoma Patient Receiving Transarterial Chemoembolization
NCT Number: NCT06478719
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Placebo|DRUG: FB-1603
Sponsor: Febico Biomedical Corp.
Collaborators: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-08-06
Locations: National Taiwan University Hospital, Taipei, 10002, Taiwan

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)

Primary Outcome Measures: Changes in the level of liver function, Changes in the level of liver function parameters, including aspartate transferase (AST), alanine transferase (ALT), or total bilirubin,, from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)
Secondary Outcome Measures: Changes in the level of liver function, Changes in the level of liver function parameters, including AST, ALT, or total bilirubin after TACE, from baseline (day 0) to Visit 7 (day 28) and Visit 8 (day 56)|Frequency and severity of adverse event (AE) during the study, Assessment of frequency and severity of adverse event (AE) during the study, up to 84 days|Clinically significant changes in blood chemistry, Clinically significant changes in blood chemistry at each applicable visit, from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84)|Clinically significant changes in coagulation test, Clinically significant changes in coagulation test at each applicable visit including international normalized ratio (INR) and prothrombin time., from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84)|Changes in measurements of indocyanine green retention (ICG), Changes in measurements of indocyanine green retention (ICG) test at each applicable visit, from baseline (day 0) to Visit 3 (day 4) and Visit 5 (day 10)|Level of liver fibrosis, Level of liver fibrosis by elastography and fibrosis-4 (FIB-4) index, at the screening visit (day -28 to -15), Visit 8 (day 56) and FV/ET (day 84)|Incidence of postembolization syndrome, Incidence of postembolization syndrome, from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28) and Visit 8 (day 56)|Length of hospital stay after TACE, Length of hospital stay after TACE, Visit 2 (day 0)|Changes in the level of quantitative HBsAg or HCV RNA, Changes in the level of quantitative HBsAg or HCV RNA measured by PCR, from screening visit (day -28 to -15) to Visit 8 (day 56) and FV/ET (day 84)