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Hepatitis b patients may be able to ditch daily pills, new trial hopes

NCT ID NCT04782375

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This study tests whether adults with chronic hepatitis B who have no liver scarring can safely stop taking antiviral drugs. The 140 participants have undetectable virus levels and negative HBeAg status. Researchers will monitor for viral relapse and liver problems over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
discontinuation of antiviral treatment
What this could lead to
If successful, this could show that some patients with chronic hepatitis B can safely stop long-term antiviral therapy without the virus coming back.
What could go wrong
This is a small, early-phase trial without a control group, so results may not apply widely. There is a risk of viral relapse or liver problems after stopping medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

140 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written informed consent prior to study entry 2. Age ≥19 years and ≤65 years at the time of screening 3. HBsAg titer \<3,000 IU/mL at the time of screening 4. Antiviral treatment continued at least 2 years and HBeAg (-) at the time of screening 5. Undetectable HBV DNA level at the time of screening 6. Serum ALT level \<80 IU/mL at the time of screening 7. Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation) 8. Ability to comply with all study requirements Exclusion Criteria: 1. Confirmed known co-infection with HCV, HIV, or HDV 2. Evidence of liver cirrhosis defined as meeting any of the following criteria: 3. Current alcohol (60g/day) or substance abuse judged by the investigator that will potentially interfere with subject compliance (1) Splenomegaly (\>12 cm) assessed by ultrasound, CT, or MRI (2) Fibroscan ≥9.0 kPa (3) Platelet count \<150,000/mm3 However, if the above criteria were satisfied at the time of antiviral treatment initiation, subjects may be eligible if they have low possibility of having liver cirrhosis with improvement in liver function by long-term antiviral treatment, following the opinion of the investigator. 4. Any history of clinical hepatic decompensation (e.g., ascites, encephalopathy, variceal hemorrhage) within 12 months prior to the screening or Child-Pugh score of ≥7 at the time of screening 5. Currently on or have received therapy with Interferon or immunosuppressant (including systemic chemotherapy) within 12 months prior to the screening 6. Requirement for chronic use of systemic immunosuppressant including, but not limited to, corticosteroid (prednisone equivalent of \>40 mg/day for \>2 weeks), azathioprine, or monoclonal antibodies 7. Received solid organ or bone marrow transplant 8. Any other clinical conditions (cardiovascular, respiratory, neurologic, or renal conditions) or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements. 9. History or current evidence of hepatocellular carcinoma (HCC), or high α-fetoprotein (AFP) \> 20 ng/mL. (But, the patients with AFP \> 20 ng/mL can be enrolled and there is no evidence of HCC by dynamic CT or MRI perfomred within 4 months prior to the screening) 10. Malignancy other than hepatocellular carcinoma within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (within 2 years prior to screening with confirmation of no evidence of disease). Subjects under evaluation for possible malignancy are not eligible. 11. Concurrent enrollment in another clinical study for other type of antiviral treatment for CHB or immune modulatory drug within 3 months prior to Screening, participation to an observational (non-interventional) clinical studies or interventional studies not using anti-HBV or immune modulatory drugs, or during the follow-up period of an interventional study are not exclusion criteria. 12. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kyung-Hee University Hospital

    Seoul, South Korea

  • Ulsan University Hospital

    Ulsan, South Korea

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Other studies related to the condition(s) this trial covers.