Recruiting

Testing a new liver fibrosis treatment alongside antiviral therapy

Plain-English translation of NCT05905172 on ClinicalTrials.gov ↗ · Source last updated June 2025 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether a medication called hydronidone can help slow liver scarring (fibrosis) in people with chronic hepatitis B. You would take the medication or a placebo for 5 years while also taking your regular antiviral medicine (entecavir). The goal is to see whether this treatment can reduce the risk of serious liver complications like cirrhosis or liver cancer.

Currently, there is no fully proven medication that can stop or reverse liver scarring caused by hepatitis B, even when antiviral drugs are working well. This trial exists to find out if this medication might help protect your liver from getting worse over time.

Do you qualify?

You likely qualify if…

you completed a related Phase III trial of this medication and finished all required visits
you have chronic hepatitis B with liver fibrosis
you understand the study and are willing to commit to 5 years of treatment
you can follow the study instructions and communicate with the research team
you signed a written consent form agreeing to participate

You likely don't qualify if…

you experienced serious liver complications (like cirrhosis, liver cancer, or liver failure) during the earlier Phase III trial
you have a different type of cancer (other than liver cancer) and are expected to live less than 1 year
you have conditions or circumstances that would make it unsafe or impossible for you to follow the study protocol
your doctor believes participating could harm you or interfere with your ability to consent

What participation looks like

You will take three capsules three times a day for 5 years — either the new medication or a placebo (dummy pill) that looks identical. You will not know which one you are taking. At the same time, you will continue taking your regular hepatitis B antiviral medicine (entecavir) once daily. You will have regular visits with the research team to check your health, do blood tests, and monitor how your liver is doing.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Trial locations(23 sites)

China

Beijing Ditan Hospital Capital Medical University, Beijing, Beijing Municipality

Shanghai General Hospital,Shanghai Jiao Tong University, Shanghai, Shanghai Municipality

Beijing youan hospital, the capital of the capital, Beijing

Tsinghua Changgeng Hospital, Beijing, Beijing

The First Affiliated Hospital of Bengbu Medical University, Bengbu