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To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Primary observation indexes:
Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment.
Secondary observation indexes :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydronidone(180mg) & Entecavir & Placebo | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 2 capsules each time; with co-administration of placebo capsule, three times a day, 2 capsules each time, namely the daily dose of the investigational product is 180mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
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| Hydronidone(270mg) & Entecavir & Placebo | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 3 capsules each time; with co-administration of placebo capsule, three times a day, 1 capsules each time, namely the daily dose of the investigational product is 270mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
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| Hydronidone(360mg) & Entecavir | Experimental | hydronidone capsule 30mg/capsule hydronidone capsule, three times a day, 4 capsules each time; namely the daily dose of the investigational product is 360mg. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
|
| Entecavir & Placebo(360mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydronidone | Drug | The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hepatic fibrosis in chronic viral hepatitis B | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LunGen Lu | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Jun Cheng | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35842120 | Derived | Cai X, Liu X, Xie W, Ma A, Tan Y, Shang J, Zhang J, Chen C, Yu Y, Qu Y, Zhang L, Luo Y, Yin P, Cheng J, Lu L. Hydronidone for the Treatment of Liver Fibrosis Related to Chronic Hepatitis B: A Phase 2 Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1893-1901.e7. doi: 10.1016/j.cgh.2022.05.056. Epub 2022 Jul 13. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000621986 | hydronidone |
| C554085 | 5-methyl-1-(4-hydroxylphenyl)-2-(1H)-pyridone |
| C413685 | entecavir |
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placebo capsule 30mg/capsule placebo capsule, three times a day, 4 capsules each time. The test groups and the control group take the entecavir capsule which is orally taken for antiviral therapy, one time a day, 0.5mg each time, oral administration on an empty stomach. |
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| Placebo | Drug |
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| Entecavir | Drug |
|
| Beijing |
| China |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |