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At sponsor's discretion
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| Name | Class |
|---|---|
| GoldenMed BioTechnology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB-BO1202 | Experimental |
| |
| DCB-BO1202+Placebo | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCB-BO1202 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in liver stiffness measurement (kPa) assessed by Fibroscan® at Final visit | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in liver stiffness measurement (kPa) assessed by (Fibroscan®) at each post-treatment visit | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai-Wen Huang, MD | Hepatitis Research Center, Department of Surgery, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D019694 | Hepatitis B, Chronic |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Placebo | Drug | 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) |
|
| DCB-BO1202+Placebo | Drug | 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) |
|
| 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 | 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 | 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 | 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 | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 |
| Overall survival rates at Week-48 and Week-96 visits | Weeks 48, 96 |
| Recurrence rate at Week-96 visit | Week 96 |
| Time to recurrence of cancer | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 |
| Incidence of adverse events (AEs) | 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 | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |