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NCT05115942 (Hydronidone in Chronic Viral Hepatitis B): BVCT ex-ante prediction vs. reported outcome

On 15 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05115942
Drug Name
Hydronidone (F351)
Drug MoA
SMAD7 agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Chronic Viral Hepatitis B
Human Patients
248
Sponsor
Gyre Therapeutics
Phase
Phase 3

Prediction of , index 1801

Prospective Prediction
Prediction Index
1801
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in fibrosis improvement superior to tirzepatide)
Technical Prediction
SUCCESS (statistically significant clinical benefit in fibrosis improvement against placebo despite negative dose-response relationship for high doses)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
219 days in advance
Readout Data Interpretation
hydronidone achieved 23% placebo-adjusted fibrosis improvement at week 52; superior to tirzepatide's 21% delta at week 52 (see add'l link below) and efruxifermin's 21% delta at week 24 (see 10.1001/jamanetworkopen.2022.31982)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B
Phase
Phase 3
Status
Completed
Enrollment
248
Lead sponsor
Beijing Continent Pharmaceutical Co, Ltd.
Conditions
Liver Fibrosis
Interventions
DRUG: Hydronidone capsules; DRUG: The placebo capsules
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-30
Primary completion
2024-10-22
Completion
2024-10-22
Primary outcomes
  • Change in Ishak stage score of liver fibrosis by greater than or equal to 1 point after 52 weeks of treatment relative to baseline. (52 weeks)

NCT05115942 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials