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 79 people across eight groups (called cohorts), with between 2 and 13 participants in each group. The trial was studying an investigational injection called ARC-520 in people with chronic hepatitis B (a long-term liver infection). The main thing researchers were trying to measure was whether participants' blood levels of a hepatitis B protein — called hepatitis B surface antigen, or HBsAg — dropped by a meaningful amount (specifically, a "1-log reduction," meaning a tenfold decrease) by week 60 of the study, after 48 weeks of receiving the treatment. The reported data shows that no results were submitted for the primary outcome measure — that is, the figures for how many participants achieved that tenfold reduction in the hepatitis B protein were not reported on ClinicalTrials.gov. Several secondary (additional) outcomes were also left without reported numbers, including data on HBsAg loss over time, time to losing the surface antigen, levels dropping below a certain threshold, and whether the body developed a protective antibody response. The one secondary outcome that did include numbers related to adverse events (unwanted health changes that occurred after dosing that were considered possibly or probably linked to the treatment). The reported data shows that across the eight cohorts, the number of participants in this category ranged from 0 to 4 per group. A smaller set of figures also appears to relate to serious adverse events, with zeros reported for the groups where data was provided — however, the data as submitted is not fully labelled, so a complete group-by-group breakdown cannot be confirmed. It is worth noting that the data shows zero participants were recorded as having "completed" the study in any of the eight cohorts, though what this specifically means in the context of this trial's design was not explained in the submitted results. Many of the planned outcome measures were not accompanied by any numbers at all, meaning a full picture of what the trial found is not available from the information submitted to ClinicalTrials.gov. 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 2 Hepatitis B Trial, Terminated
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 between 18 and 75 years old (male or female)
- You are willing and able to provide written consent to participate
- Your heart tracing test (ECG) at the screening visit shows no significant problems
- You have been diagnosed with a long-term (chronic) hepatitis B virus (HBV) infection, either HBeAg negative or positive
- A specific hepatitis B marker in your blood (HBsAg) tests positive during screening
- You have never been treated with certain hepatitis B medicines called PEG IFN alpha 2a, entecavir (ETV), or tenofovir (TDF)
- You have not taken any antiviral medicines for hepatitis B (called nucleoside/nucleotide analogs) in the past 2 years
- You and your partner are willing to use two forms of contraception at the same time during the trial (such as a hormonal contraceptive plus a barrier method like a condom)
Who may not be able to join:
- You are pregnant or currently breastfeeding
- You have had signs of hepatitis flare-up or another serious infection in the 4 weeks before screening
- You have used or may need blood thinners, steroid medicines, or immune-suppressing medicines in the past 14 days
- You have taken prescription medicines in the past 14 days, with some exceptions such as certain pain relievers, blood pressure medicines, most cholesterol medicines (not rosuvastatin), topical creams, or hormonal contraceptives (confirm with trial site)
- You have a history of an autoimmune disease that is poorly controlled, or any history of autoimmune hepatitis
- You have a personal or family history of an inherited cholesterol condition (familial hypercholesterolemia)
- You are living with HIV
- You have hepatitis C or a history of hepatitis D (delta) infection, unless you are in a specific group where hepatitis D is allowed (confirm with trial site)
- Your blood pressure is higher than 170/100 mmHg and is not well controlled with medication
- You have a history of irregular heart rhythms
- You have a family history of certain inherited heart conditions (long QT syndrome, Brugada syndrome) or unexplained sudden heart death in the family
- You have had serious heart problems such as heart failure, unstable chest pain, or a heart attack within the past 6 months
- You have a history of cancer, except for certain minor skin cancers or early-stage cervical cancer that have been fully treated
- You have had major surgery within 1 month before screening
- You regularly drink more than 14 units of alcohol per week and have done so in the past 6 months
- You have used recreational drugs such as cocaine, PCP, or methamphetamines within the past year
- You have a history of allergy to bee stings
- You have a significant history of liver disease caused by alcohol, scarring of the liver (cirrhosis), or certain inherited liver conditions (Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency)
- You currently have a bile duct or gallbladder problem such as inflammation or blockage
- You have a serious ongoing health condition that is not well controlled
- You have any medical, mental health, or personal situation that could affect your ability to follow the trial rules or could put you at extra risk
- You have had a blood clotting problem or stroke in the past 6 months, or you are currently taking blood-thinning medication
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
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
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline
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.