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 161 people in total across three groups. Group A had 101 participants who received a medication called PEG-interferon (a type of injection used in hepatitis B treatment) and did not have advanced liver scarring. Group B had 50 participants who received no treatment and also did not have advanced liver scarring. Group C had 10 participants who received PEG-interferon and did have advanced liver scarring. The trial was measuring several things related to hepatitis B virus (HBV) activity in the body, including whether certain proteins in the blood changed over the course of treatment — specifically looking at what happened 24 weeks after treatment ended. The reported data shows the following for the main result (called the primary outcome), which looked at a change in blood proteins known as "HBeAg seroconversion" — meaning a specific hepatitis B protein disappeared and a protective antibody appeared in its place: this was recorded in 25.7% of participants in Group A (those who received the medication) compared with 6% in Group B (those who received no treatment). For some of the other measurements taken at the same 24-week point after treatment: loss of that same protein without the antibody check was also 25.7% in Group A versus 6% in Group B; a different protein called HBsAg disappearing with an antibody appearing was recorded in 7.9% of Group A versus 0% in Group B; normal liver enzyme levels (ALT) were recorded in 51.5% of Group A versus 12% in Group B; and low levels of the virus in the blood were recorded in 33.7% (Group A) versus 4% (Group B) at one threshold, and 28.7% versus 2% at a stricter threshold. Results for Group C were not reported in these outcome measures. 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 29689122) ↗
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 are male or female, between 3 years old and under 18 years old at the start of the trial
- You have had a positive test for hepatitis B surface antigen (a sign of hepatitis B infection) for more than 6 months
- You have a positive HBeAg test and detectable hepatitis B virus in your blood at the screening visit
- You have had a liver biopsy within the past 2 years that shows advanced scarring of the liver but not full cirrhosis
- Your liver is still functioning reasonably well (what doctors call "compensated liver disease," Child-Pugh Class A)
- Your blood tests show raised liver enzyme levels (ALT), which is a sign of liver inflammation
- Your thyroid gland is working normally at the time of screening
Who may not be able to join:
- You have been diagnosed with cirrhosis (severe scarring of the liver)
- You have taken experimental drugs or approved treatments for hepatitis B within the 6 months before the trial starts, or you are expected to need other antiviral treatments during the trial
- You have a known allergy or sensitivity to peginterferon (a medication used to treat hepatitis B)
- You tested positive at screening for hepatitis A, hepatitis C, hepatitis D, or HIV
- You have a history of another long-term liver disease other than hepatitis B
- You have a history of bleeding from swollen veins in the food pipe (esophageal varices)
- Your liver disease is at an advanced stage where it is no longer functioning well (such as having fluid build-up in the abdomen, or Child-Pugh Class B or C)
- You have a history of a disease where the immune system attacks the body (confirm with trial site)
- You are pregnant or currently breastfeeding
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.