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 751 adults with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were split into four groups and given different treatment combinations: one group received two medicines together (tenofovir, or TDF, plus pegylated interferon, or Peg-IFN) for 48 weeks; a second group received TDF for 48 weeks but Peg-IFN for only the first 16 weeks; a third group received TDF alone for 120 weeks; and a fourth group received Peg-IFN alone for 48 weeks. The trial's main goal was to measure how many people in each group lost a specific protein on the surface of the hepatitis B virus — called HBsAg — by around week 72, since losing this protein is considered a notable marker in hepatitis B. The reported data shows that for the primary measurement at week 72, approximately 9.1% of participants in the TDF-plus-Peg-IFN (48-week) group had lost HBsAg, compared with about 2.8% in the Peg-IFN-alone group and 0% in the TDF-alone group. For the shorter combination (TDF 48 weeks plus Peg-IFN 16 weeks), the reported figure was approximately 2.8% — similar to the Peg-IFN-alone group. The reported data shows these figures remained broadly similar when checked again at weeks 96 and 120. For a related secondary measure — the body developing antibodies against that same surface protein (called seroconversion) — the TDF-plus-Peg-IFN (48-week) group showed figures of around 8.1% at weeks 72 and 96, rising to about 10.1% at week 120, while the other groups showed notably lower figures. Separately, the proportion of participants who lost another hepatitis B marker called HBeAg was also tracked; in those not requiring retreatment at week 72, figures ranged from roughly 14.7% to 35.5% depending on the group, with similar patterns seen at week 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 26453773) ↗
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 4 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:
- Adults between 18 and 75 years old who have had a long-term hepatitis B infection (confirmed by blood tests) for at least 6 months
- People who have never taken anti-hepatitis B medication, OR people who took oral hepatitis B medication but stopped at least 24 weeks before the screening visit
- People who test either positive or negative for a specific hepatitis B marker called the "e antigen" (confirm with trial site)
- People whose hepatitis B virus levels in the blood are above certain amounts, depending on their e antigen result (confirm with trial site for exact numbers)
- People whose liver enzyme levels (a sign of liver health) fall within a specific range — not too low and not too high
- People whose kidneys are working well enough (above a certain threshold in a kidney function test)
- Women who could become pregnant must have a negative pregnancy test before starting
- Women who are sexually active and could become pregnant must agree to use an approved form of contraception during the study and for 30 days after the last dose
- Women who are breastfeeding must agree to stop before starting the study treatment
Who may not be able to join:
- People who have significant liver scarring, cirrhosis, or serious liver failure
- People who have liver cancer or signs of it
- People with serious kidney, heart, lung, nerve, autoimmune, or bone diseases
- People whose blood counts (white blood cells, platelets, or red blood cells) are below certain levels
- People with a history of severe depression or serious mental health conditions
- People with a thyroid disorder
- People who are also infected with HIV, hepatitis C, or hepatitis D
- Women who are pregnant
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: Belinda Jump, Gilead Sciences
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
19 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.