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 379 adults with hepatitis B — 182 in a group taking a medicine called entecavir (ETV) alone, and 197 in a group taking entecavir combined with a second medicine called tenofovir (TDF). The main thing the trial was measuring was what proportion of participants had their hepatitis B virus reduced to a very low level (below 50 IU/mL, a standard threshold used in blood tests) after 96 weeks of treatment. A number of secondary measurements were also tracked, including virus levels at earlier time points, liver enzyme levels in the blood, and how many participants had the virus reduced to even lower detection thresholds. The reported data shows that at the 96-week mark — the primary endpoint — 76.4% of participants in the entecavir-only group and 83.2% in the combination group had virus levels below that low threshold. For secondary measures, the reported data shows that when participants were split by a particular blood marker called HBeAg status, the proportions achieving low virus levels ranged from around 61% to 93% depending on the group, the time point (48 or 96 weeks), and HBeAg status. Using an even stricter detection threshold, between roughly 58% and 77% of participants across both groups had virus levels that fell below the lowest detectable limit at various time points. For liver enzyme (ALT) normalisation — a measure of whether a liver-related marker returned to a normal range — the reported figures ranged from approximately 68% to 83% across the two groups at weeks 48 and 96. 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 ↗ · Read the linked publication on PubMed (PMID 22643350) ↗
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 been diagnosed with a long-term (chronic) Hepatitis B virus infection, whether a specific protein marker called "e antigen" is present in your blood or not
- You have never previously been treated with a type of antiviral medication called nucleoside or nucleotide drugs for Hepatitis B
- You are male or female and at least 16 years old (or the minimum legal age of consent in your country)
- Your liver is still functioning well enough to compensate for the disease (confirm with trial site)
- If your "e antigen" test is positive, the amount of Hepatitis B virus in your blood is above a certain level (confirm exact level with trial site)
- If your "e antigen" test is negative, the amount of Hepatitis B virus in your blood is above a certain (lower) level (confirm exact level with trial site)
- A specific liver enzyme in your blood called ALT is within a particular range — not too low and not too high (confirm exact range with trial site)
Who may not be able to join:
- Your liver disease has progressed to a serious stage where the liver can no longer function properly (known as decompensated cirrhosis)
- You are also infected with HIV, Hepatitis C, or Hepatitis D virus
- Certain blood test or lab results fall outside the ranges set out by the trial guidelines (confirm specific values with trial site)
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: Bristol-Myers Squibb, Bristol-Myers Squibb
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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
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.