Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04465916) enrolled 26 people in total — 19 in the experimental arm (receiving vonafexor on top of their existing hepatitis B treatment) and 7 in the control arm (receiving their existing treatment alone). All 19 people in the experimental arm completed the study, while 6 out of 7 in the control arm completed it. The trial was primarily measuring changes in a protein called HBsAg (hepatitis B surface antigen — a marker found in the blood of people with hepatitis B infection), looking at how much its level changed over 16 weeks of treatment. The change was measured on a logarithmic scale, which is a way of expressing large ranges of numbers more compactly. The reported data shows that the average change in HBsAg levels from the start to week 16 was −0.029 log10 IU/mL in the experimental arm and −0.066 log10 IU/mL in the control arm. In plain terms, both groups showed a very small decrease in this blood marker over the 16-week period, with the control arm showing a slightly larger decrease than the experimental arm. The reported data also shows results for a secondary measure called "virologic failure" — meaning a meaningful rise in the amount of hepatitis B virus detected in the blood. According to the results reported on ClinicalTrials.gov, zero participants in either group experienced virologic failure at any of the four time points measured (week 16, and then at weeks 20, 28, and 40 during a follow-up period). It is worth noting that this was a small trial with 26 participants in total, and the results as submitted reflect only what was observed in this specific group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Hepatitis B Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been taking a stable hepatitis B antiviral medication (either entecavir or tenofovir disoproxil fumarate) for at least 12 months before the study screening date.
- Your hepatitis B virus is well controlled by your medication — meaning the virus is at an undetectable or very low level in your blood, but a specific protein from the virus (HBsAg) is still present above a certain level.
- You have had a liver scan (to check for liver cancer or related conditions) either within the past 6 months or at the time of screening.
- You are not pregnant, not planning to become pregnant during the study, and if pregnancy is possible for you, you have had a negative pregnancy blood test at screening.
Who may not be able to join:
- You work for a company involved in running or sponsoring this clinical trial.
- You have been diagnosed with liver cancer or a disease affecting the pancreas or bile ducts.
- You have a low white blood cell count (specifically, low neutrophils) confirmed by two tests during the screening period (confirm with trial site).
- You have a condition called Gilbert syndrome, which affects how the body processes a substance called bilirubin.
- Your liver function tests have recently gotten significantly worse, or you have symptoms suggesting your liver is not working well.
- You have a known liver disease other than hepatitis B.
- You have a history of severe liver scarring (cirrhosis) or liver failure, including fluid build-up in the abdomen, confusion caused by liver problems, or enlarged veins in the food pipe.
- Your liver stiffness scan results suggest significant liver scarring, based on specific measurements taken at the start of the study (confirm with trial site).
- You have a known history of alcohol abuse or drink heavily on a daily basis.
- You have a significant problem with your immune system, such as an immune deficiency condition.
- You have used any anti-hepatitis B medication other than the two approved antivirals for this trial within the past 90 days before screening.
- Your kidneys are not working well enough, based on a blood test measuring kidney function.
- Your thyroid hormone levels are outside the normal range, based on blood tests at screening.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ENYO PHARMA Investigative site KR04, Pusan, South Korea
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.