Hepatitis b patients may be able to ditch daily pills, new trial hopes
NCT ID NCT04782375
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Massive Real-World database aims to map how chronic diseases interact
- Can a Two-Drug combo wipe out hepatitis b for good?
- Can a new pill push hepatitis b virus to undetectable levels?
- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?