Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3… (NCT05115942) | Clinical Trial Compass
CompletedPhase 3
Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.
China248 participantsStarted 2021-12-30
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
✓. 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.
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.
✕
What they're measuring
1
Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline.