Clinical trial NCT07017426: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Decompensated Hepatitis B Cirrhosis
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 lactating women or those with fertility plans during the study period;
* 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;
* Individuals who have taken traditional Chinese medicine such as Fuzheng Huayu within the past 6 months;
* Other situations that have participated in other intervention studies within the previous 3 months or are deemed unsuitable for inclusion by the researchers;
* The population diagnosed with liver cancer 3 months after enrollment.

Primary outcomes:
measure: the cumulative incidence of recurrent decompensation events
timeFrame: 1 year
Secondary outcomes:
measure: the cumulative incidence of recompensation
timeFrame: 1 year
measure: the incidence of liver failure
timeFrame: 1 year and 2 year
measure: the incidence of liver cancer
timeFrame: 1 year and 2 year
measure: the incidence of liver disease-related deaths
timeFrame: 1 year and 2 year
Other outcomes:
Locations:
Study officials:
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