NCT07017426Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 432 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Zhiyun Yang
- Diseases
- Hepatitis B
- NCT number
- NCT07017426
What you commit to
- Study type: Interventional
- Planned participants: 432
- From 1 Jul 2025 to the primary completion date, 1 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who plan to undergo organ transplantation or have already undergone organ transplantation;
- Other situations that have participated in other intervention studies within the previous 3 months or are deemed unsuitable for inclusion by the researchers;
Other illness
- 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;
- For those who are allergic to tonifying the body and removing blood stasis, nucleoside (acid) analogues, or drugs, or who meet any contraindications in the research drug instructions;
- The population diagnosed with liver cancer 3 months after enrollment.
Other
- Pregnant or lactating women or those with fertility plans during the study period;
- Individuals who have taken traditional Chinese medicine such as Fuzheng Huayu within the past 6 months;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
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This page is information, not medical advice. Discuss any trial with your doctor.