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 116 participants in each of two groups — one group received a medicine called telbivudine (600 mg) and the other received lamivudine (100 mg), both existing antiviral treatments for hepatitis B. The trial was measuring what researchers called a "clinical response" — a combined result where a participant's hepatitis B virus levels in the blood dropped below a set level, their liver enzyme (ALT) readings returned to a normal range, and their liver function score (measured by a tool called the Child-Turcotte-Pugh or CTP score, which runs from 5 to 15, with higher numbers meaning more liver damage) either stayed stable or improved. Participants were followed for up to 104 weeks (about two years). The reported data shows that, looking at the primary outcome, the numbers of participants recorded as achieving a clinical response at various points were broadly similar between the two groups. For the secondary outcomes, the reported data shows the average time until a participant first reached a clinical response was around 138 days in the telbivudine group and 125 days in the lamivudine group. The reported duration that a clinical response was maintained averaged around 473 days for telbivudine and 456 days for lamivudine. For changes in the CTP liver function score at week 52, the reported data shows 36 telbivudine participants and 44 lamivudine participants showed improvement, 60 and 52 respectively showed stabilisation, and 18 in each group showed worsening. At week 104, 44 and 46 showed improvement, 42 and 38 showed stabilisation, and 28 and 30 showed worsening. A number of other sub-measures were also reported, with similarly close figures between the two groups. 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 been diagnosed with long-term (chronic) hepatitis B that has caused serious liver problems, meaning your liver is no longer working properly (this is called "decompensated" hepatitis B)
- A doctor has assessed your liver condition using a scoring system called the Child-Turcotte-Pugh score, and your score is higher than 7, indicating significant liver disease
- There is medical evidence that you have scarring of the liver (cirrhosis) or high blood pressure in the blood vessels around the liver (confirm with trial site)
Who may not be able to join:
- You are currently pregnant or breastfeeding
- You also have hepatitis C, hepatitis D, or HIV in addition to hepatitis B
- You have ever taken certain anti-hepatitis B medications, specifically lamivudine, adefovir, or any experimental hepatitis B antiviral drug (nucleoside or nucleotide analog), at any point in the past
- You have received interferon therapy or any other treatment designed to boost your immune system against hepatitis B within the last 12 months before joining the study
Important: Always verify eligibility with the trial site directly before applying.
Please note that additional eligibility requirements not listed here may also apply — the trial site will be able to give you the full details.
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
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
Number of Participants With Clinical Response
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.