The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)
The study will include the first 188 subjects who are randomized. The purpose of study is to collect efficacy results to evaluate treatment effect on the primary endpoint. The second endpoints is to evaluate drug safety on the incidence of the primary endpoint through the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
The assignment will be as follows: (Each DCB-BO1202 300mg capsule contains 150mg active ingredient) DCB-BO1202: 4 DCB-BO1202 300mg capsules, t.i.d., orally. Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)
The assignment will be as follows: Placebo: 4 matched placebo, t.i.d., orally. Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)
The assignment will be as follows: (Each DCB-BO1202 300mg capsule contains 150mg active ingredient) DCB-BO1202+Placebo: 2 DCB-BO1202 300mg capsules plus 2 matched placebo, t.i.d., orally. Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) \* 8 cycles)
National Taiwan University Hospital
Taipei, Taiwan
Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit
Time frame: 96 weeks
Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84
Changes from baseline in biomarkers associated with liver fibrosis at each post-treatment visit compared to baseline
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline in hepatic functions such as liver enzymes, albumin, direct bilirubin and international normalize ratio (INR) at each post-treatment visit compared to baseline
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Change from baseline in log10 HBV deoxyribonucleic acid (DNA) measured by Polymerase chain reaction (PCR) assay at each post-treatment visit and each of post-study follow-up visits compared to baseline
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Transition of HBV DNA detectable status (e.g. <500 copies/mL) by PCR at each post-treatment visit from baseline
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue total score and sub-scores compared to baseline at each post-treatment visit
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Overall survival rates at Week-48 and Week-96 visits
Time frame: Weeks 48, 96
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Recurrence rate at Week-96 visit
Time frame: Week 96
Time to recurrence of cancer
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Incidence of adverse events (AEs)
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Changes from baseline to post-treatment visits in vital signs, laboratory examination, and physical examinations results
Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96