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 enrolled 62 people with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were divided into three groups: 26 people received a combination of pegylated interferon alfa-2a (an immune-boosting injection) plus one of two antiviral tablets (lamivudine or entecavir); 33 people were observed without any treatment; and 3 people received interferon alone. The trial's main goal was to measure how many participants lost a specific protein on the surface of the hepatitis B virus — called hepatitis B surface antigen, or HBsAg — at 24 weeks after finishing treatment or observation, as losing this marker is considered a notable milestone in managing the infection. The reported data shows that, for the primary goal of HBsAg loss at 24 weeks after treatment or observation, 3.8% of participants in the treated combination group achieved this (roughly 1 in 26), while 0% of the untreated group did. For several of the secondary measurements — including loss of another viral protein (HBeAg), development of protective antibodies, and virus levels in the blood falling below certain thresholds — the percentages reported across the treated and untreated groups generally ranged from 0% to around 15%, with some variation depending on the specific measure and time point. The small number of participants in the interferon-only group (3 people) means no separate percentage figures were reported for that group across most outcomes. 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 3 Hepatitis B Trial, Completed
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 tested positive for two specific hepatitis B markers (called HBsAg and HBeAg) for more than 6 months before the study starts.
- Blood tests show a measurable level of hepatitis B virus in your blood (above a certain amount), confirmed on at least 2 separate occasions at least one month apart, with the most recent test done within 42 days before the study starts.
- Your liver is still functioning reasonably well (doctors would classify this as "compensated" liver disease, meaning it has not yet failed — confirm with trial site).
- Either: you had a liver biopsy within the past 2 years showing little or no scarring, AND your liver enzyme levels (ALT) have been consistently normal for the past 6 months; OR your liver enzyme levels (ALT) have been consistently normal for the past year (checked at least 3 times, each at least a month apart), AND a recent ultrasound scan showed no signs of liver cancer, severe scarring, or an enlarged spleen.
Who may not be able to join:
- You have previously taken any experimental or approved medicines that treat hepatitis B (with a small exception for a short course of acyclovir for cold sores taken more than a month before the study).
- You have taken part in another clinical trial or received an experimental drug within the past 6 months.
- You have a known allergy or sensitivity to certain antiviral or interferon-based medicines used in this trial (including interferon, pegylated interferon-alfa-2a, lamivudine, or entecavir).
- Your screening blood tests come back positive for hepatitis A (recent infection), hepatitis C, hepatitis D, or HIV.
- Your liver disease has progressed to a more serious stage, showing signs such as fluid build-up in the abdomen or swollen veins (confirm with trial site).
- You have advanced liver scarring (fibrosis) or cirrhosis.
- An ultrasound scan suggests there may be liver cancer present (all participants must have had a liver ultrasound within 6 months before the study starts).
- You have, or have had, another long-term liver condition unrelated to hepatitis B, such as a metabolic liver disease (for example, hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency).
- You have had a problem with substance misuse or abuse within the past 6 months.
- You are a woman of childbearing age or a man who is sexually active and unwilling to use reliable contraception during the trial and for 90 days after treatment ends.
- You are pregnant, breastfeeding, or have a positive pregnancy test within 24 hours of the study start date.
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: Clinical Trials, Hoffmann-La Roche
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.