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Hepatitis B, ChronicPhase 4ADAPTNCT04782375

Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B

A Phase 4 study testing Stop group in people with Hepatitis B, Chronic, run by Asan Medical Center at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, Prospective Open-label Single Arm Trial Chronic hepatitis B male and female adults on antiviral treatment for hepatitis B, without cirrhosis who are currently HBV DNA (-) and HBeAg (-) To evaluate the safety and efficacy of stopping long-term antiviral therapy in chronic hepatitis B patients without… Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Stop group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
4 sitesSouth Korea
Study dates
1 Sep 2021to 30 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent prior to study entry
  • Age ≥19 years and ≤65 years at the time of screening
  • HBsAg titer <3,000 IU/mL at the time of screening
  • Antiviral treatment continued at least 2 years and HBeAg (-) at the time of screening
  • Undetectable HBV DNA level at the time of screening
  • Serum ALT level <80 IU/mL at the time of screening
  • Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation)
  • Ability to comply with all study requirements

Who cannot join

  • Confirmed known co-infection with HCV, HIV, or HDV
  • Evidence of liver cirrhosis defined as meeting any of the following criteria:
  • 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.
  • 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
  • Currently on or have received therapy with Interferon or immunosuppressant (including systemic chemotherapy) within 12 months prior to the screening
  • 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
Show all 12Show fewer
  • Received solid organ or bone marrow transplant
  • 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.
  • 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)
  • 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.
  • 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.
  • Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Asan Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung-Hee University Hospital

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

About this study

Official title: A Multicenter Prospective Open-label Single Arm Trial to Safely Discontinue Antiviral Treatment in Patients With HBeAg-Negative Chronic Hepatitis B and Low HBsAg Concentrations (ADAPT)

Multicenter, Prospective Open-label Single Arm Trial Chronic hepatitis B male and female adults on antiviral treatment for hepatitis B, without cirrhosis who are currently HBV DNA (-) and HBeAg (-) To evaluate the safety and efficacy of stopping long-term antiviral therapy in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-)

Read the detailed description

This clinical trial is a multicenter, Prospective Open-label Single Arm Trial to evaluate the safety and efficacy of stopping long-term antiviral therapy in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-).

Approximately 140 subjects meeting eligibility criteria will be enrolled a Intervention Arm as below;

  • Intervention Arm: 140 subjects, discontinue antiviral treatment (stop group)

Participants are scheduled to be followed up to 48 weeks. Patients are retreated with nucleos(t)ide analogues that had been prescribed previously if they fulfill one of the following criteria: 1) HBV DNA >2,000 IU/mL, 2) at the participant's request or at the treating investigator's discretion, 3) progression to liver cirrhosis, or 4) development of hepatocellular carcinoma.

Being tested
Stop group
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stop groupDrug

    Also called discontinue antiviral treatment

    discontinue antiviral treatment

Study groups in NCT04782375
Study groupRoleWhat they receive
Treatment Arm AExperimentaldiscontinue antiviral treatment
Receives: Drug: Stop group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. virological relapse

    Proportion of virological relapse defined as HBV DNA ≥2,000 IU/mL

    Measured: Change from baseline in HBV DNA result in 48 weeks

Secondary outcomes (5)

  1. Biochemical relapse

    ALT ≥80 U/L with HBV DNA ≥2000 IU/mL

    Measured: From baseline, clinical events will be collected within 48 weeks

  2. ALT flare

    ALT ≥200 U/L after documented virological relapse

    Measured: 48 weeks

  3. Retreatment

    Retreatment

    Measured: 48 weeks

  4. HBsAg seroclearance

    HBsAg seroclearance

    Measured: 48 weeks

  5. Hepatic decompensation

    ascites, encephalopathy, variceal bleeding, or jaundice

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2021
  2. Study start1 Sep 2021
  3. Primary completion19 Aug 2024
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782375
Sponsor's protocol ID
AMC 2021-0135
Acronym
ADAPT
Status last verified
Aug 2026
First submitted
2 Mar 2021
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stop group in people with Hepatitis B, Chronic, run by Asan Medical Center at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

virological relapse (time frame: Change from baseline in HBV DNA result in 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04782375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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