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| Name | Class |
|---|---|
| Shenzhen Third People's Hospital | OTHER |
| Beijing Ditan Hospital | OTHER |
| Beijing 302 Hospital | OTHER |
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This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue_yu syndrome and have an aMAP score >60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Standard antiviral therapy + Biejia-Ruangan compound | Experimental | receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy. |
|
| Placebo Comparator: Standard antiviral therapy + Placebo | Placebo Comparator | receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biejia-Ruangan compound | Drug | receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up | Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up | From enrollment to the end of treatment at 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Non-HCC liver-related events and other the clinical changes or incidence rates |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Fan | Contact | 020-62786534 | rongfansmu@163.com |
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| Biejia-Ruangan compound simulant | Drug | receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy |
|
| From enrollment to the end of treatment at 96 weeks |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006528 | Carcinoma, Hepatocellular |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| 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 |
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