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NCT07017426: FZHYRORDFDHBLC
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
NA trial testing Fuzheng Huayu tablets in Decompensated Hepatitis B Cirrhosis in 432 participants. Not yet recruiting.
1 July 2027
Quick facts
| Lead sponsor | Zhiyun Yang |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 432 |
| Start date | 1 July 2025 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 July 2027 |
Drugs / interventions tested
- Fuzheng Huayu tablets — full drug profile →
- Placebo Comparator
Conditions studied
- Decompensated Hepatitis B Cirrhosis — all drugs for Decompensated Hepatitis B Cirrhosis →
Sponsor
Zhiyun Yang — full company profile →
Who can join
Adults 18 to 80, any sex, with Decompensated Hepatitis B Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07017426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Decompensated Hepatitis B Cirrhosis
Currently open trials in the same condition.
- NCT07413549 — Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrh · Phase 1, PHASE2 · recruiting
Other Zhiyun Yang trials
Trials by the same sponsor.
- NCT06923176 — Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatme · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07017426 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhiyun Yang
- Last refreshed: 12 June 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing