A Phase 3 interventional study of Hydronidone capsules and The placebo capsules in Liver Fibrosis, sponsored by Beijing Continent Pharmaceutical Co, Ltd.. Completed at 44 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Beijing Continent Pharmaceutical Co, Ltd. · Phase 3, Interventional, and Treatment
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.
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 patients. Both groups were treated with entecavir antiviral basic therapy.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 248 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Beijing Continent Pharmaceutical Co, Ltd. is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Patients were orally received hydronidone capsules,3 capsules each time, t.i.d. for 52 weeks.
Drug: Hydronidone capsules
Patients were orally received placebo capsules,3 capsules each time, t.i.d. for 52 weeks.
Drug: The placebo capsules
After randomization, the experimental group were orally received hydronidone capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d,30 min before meals for 52 weeks.
Also known as: F351
After randomization, The control group were orally received placebo capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d, 30 min before meals for 52 weeks.
Also known as: N
Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.
Clinically, the liver pathology scoring system, Ishak system, is widely used make a detailed and accurate assessment of the degree of parenchymal fibrosis or cirrhosis of the nontumorous liver. Ishak system uses a scale of 7 stages (scores 0-6) for the degree of fibrosis; the higher the score, the higher degree the severity of the disease.
Time frame: 52 weeks
Change in liver inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline but with no progression of fibrosis.
Scheuer score system is a liver pathology scoring system used for the diagnosis of liver inflammation and fibrosis pathology clinically; In the present trial, Scheuer system for scoring necroinflammatory activitt in chronic hepatitis will be used(G0-G4),the higher the score, the higher degree the severity of the disease.
Time frame: 52 weeks
Change in liver tissue inflammation grade by greater than or equal to 1 grade after 52 weeks of treatment relative to baseline.
Scheuer score system is a liver pathology scoring system used for the diagnosis of liver inflammation and fibrosis pathology clinically; In the present trial, Scheuer system for scoring necroinflammatory activitt in chronic hepatitis will be used(G0-G4),the higher the score, the higher degree the severity of the disease.
Time frame: 52 weeks
Change in liver stiffness measurement values via transient elastography LSM (kPa)
Change in liver stiffness measurement values via transient elastography LSM (kPa) values relative to baseline after 52 weeks of treatment.
Time frame: Screening period/baseline and weeks 12, 24, 36, and 52 after treatment .
Negative conversion (below the lower limit of detection) and the extent of decrease in HBV DNA
Negative conversion (below the lower limit of detection) and the extent of decrease in HBV DNA after 52 weeks of treatment.
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Normalization and the degree of improvement of the indicators of liver function ALT after 52 weeks of treatment.
ALT is one of the indicators to assess liver function and detect liver damage. When hepatic cells are affected by injury or disease, ALT is released into the blood, resulting in elevated ALT levels in the blood.
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（AFP test）
AFP test: the serum AFP will be detected.
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:AE
Adverse events (AEs) refer to any adverse medical events that occur after the patient takes the study drug and can manifest as signs and symptoms, disease, or abnormal laboratory tests, but are not necessarily consequently related to the study drug. Information on AEs and Concomitant medications occurring in patients will be collected at the time points specified in the study schedule. AEs will be evaluated with reference to the Common Adverse Events Evaluation Criteria (NCI-CTCAE version 5.0).
Time frame: 52 weeks
Safety endpoints:Laboratory examination（Metabolic panel-AST）
Metabolic panel: The panel includes aspartate aminotransferase (AST)，which is one of the indicators to assess liver function and detect liver damage.
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-GGT）
Metabolic panel: The panel includes gamma-glutamyl transpeptidase (GGT),which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-ALP）
Metabolic panel: The panel includes alkaline phosphatase (ALP),which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-TP）
Metabolic panel: The panel includes total protein (TP), which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-A）
Metabolic panel: The panel includes albumin (A) , which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-TBiL）
Metabolic panel: The panel includes total bilirubin (TBiL) , which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Safety endpoints:Laboratory examination（Metabolic panel-DBiL）
Metabolic panel: The panel includes direct bilirubin (DBiL) , which is one of the indicators to assess liver function .
Time frame: Screening period/baseline and weeks 4, 8, 12, 24, 36, and 52 after treatment.
Plan to share: No
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Beijing Continent Pharmaceutical Co, Ltd.