Not Yet RecruitingNot Applicable

Fuzheng Huayu Tablets Reduce the Occurrence of Re-Decompensation Events in Patients With First Decompensation of Hepatitis B-Related Liver Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

432 participantsStarted 2025-07-01

Plain-language summary

This study aims to conduct a prospective, multicenter, double-blind, randomized, placebo-controlled trial. The planned sample size is 432 patients, with the ratio of the Fuzheng Huayu group to the placebo control group being 1:1. Participants will be randomly assigned to the two groups using a stratified block randomization method at the central level. The Fuzheng Huayu group (Fuzheng Huayu tablets combined with conventional antiviral therapy) and the placebo group (placebo combined with conventional antiviral therapy) will be treated for 48 weeks, followed by a 96-week follow-up. The study period will last for a total of 2 years. The cumulative incidence of recurrent decompensation events within 1 year, the cumulative incidence of recompensation within 1 year, the incidence of liver failure, liver cancer, and liver disease-related deaths will be analyzed. The efficacy and safety of Fuzheng Huayu tablets in reducing the recurrence of decompensation events in patients with first-time decompensated hepatitis B cirrhosis will be clarified, providing a basis for clinical practice.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Voluntarily joining the group, able to understand and sign informed consent forms; * Age range: 18-80 years old, gender not limited; * HBsAg positive for ≥ 6 months during screening; * Complies with traditional Chinese medicine syndrome types: blood stasis obstructing collaterals, liver and kidney deficiency syndrome; * The first decompensated event, which meets the diagnostic criteria for decompensated cirrhosis in the "Diagnosis and Treatment Guidelines for Cirrhosis (2019 Edition)": (1) having diagnostic evidence for cirrhosis; (2) Complications related to portal hypertension may occur, such as ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc. Exclusion Criteria: * Merge hepatitis A, C, D, E, and/or HIV infections; * Merge autoimmune liver disease, alcoholic liver disease, drug-induced liver disease and other liver diseases; * Patients with combined malignant tumors; * History of splenectomy and transjugular intrahepatic portosystemic shunt surgery; * Individuals with neurological and psychiatric disorders, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression); * Individuals with severe heart, lung, kidney and other organ disorders; * Individuals who plan to undergo organ transplantation or have already undergone organ transplantation; * Pregnant or lactati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the cumulative incidence of recurrent decompensation events

Timeframe: 1 year

Trial details

NCT IDNCT07017426

SponsorZhiyun Yang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

Contact for this trial

Zhi yun Yang, Doctor

+86 13439696988 yangzhiyun2016@163.com

View on ClinicalTrials.gov More Decompensated Hepatitis B Cirrhosis trials