Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Viral Hepatitis B Phase 3 Trial.

Study Overview
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Brief Summary
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This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study. The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.

Detailed Description
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248 patients with chronic viral hepatitis B liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. Each group has 124 subjects. Both groups were treated with entecavir antiviral basic therapy.

Official Title
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Hydronidone for the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B:Randomized,Double-blind,Placebo-controlled,Entecavir Basic Treatment,Multicentre Phase 3 Trial.

Conditions
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Liver Fibrosis

Intervention / Treatment
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* Drug: Hydronidone capsules
* Drug: The placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3). Positive HBV DNA. ALT < 8 x ULN (standard upper limit). No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment. 3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc. The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan. Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form. Exclusion Criteria: Massive upper gastrointestinal hemorrhage within 3 months before enrolment. Total bilirubin (TBIL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBIL > 2×ULN. AFP > 100 μg/L although there was no indication of liver cancer. Platelets (PLT) ≤60×109/L. Prothrombin activity (PTA) < 50% or INR > 1.5. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor. Body mass index (BMI) > 30 kg/m2. Patients with decompensated liver cirrhosis and liver malignant tumor. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders . Women who are pregnant and/or breastfeeding. Have participated in clinical trials of other drugs in the last 3 months. The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydronidone group<br>Patients were given three capsules of hydronidone three times a day for 52 weeks. | Drug: Hydronidone capsules<br>* After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 52 weeks.<br>* Other names: F351;|
| Placebo Comparator: The placebo group<br>Patients were given three capsules of placebo three times a day for 52 weeks. | Drug: The placebo capsules<br>* After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 52 weeks.<br>* Other names: N;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological score of Ishak stage | After 52 weeks of treatment, the proportion of Ishak of liver fibrosis decreased by more than 1 point from baseline | 52 weeks |