Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B

NCT04782375 | Active Not Recruiting Phase 4

• 1 other identifier: AMC 2021-0135
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 9

Brief 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 cirrhosis who are currently HBV DNA (-) and HBeAg (-)

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• virological relapse

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

  Change from baseline in HBV DNA result at 6month and 12month

Secondary Outcomes (2)

• hospital admission

  From baseline, clinical events will be collected within 12month

• Proportion of clinical relapse

  at 6month and 12 month

Study Arms (1)

Treatment Arm A

EXPERIMENTAL

discontinue antiviral treatment

Drug: Stop group

Interventions

Stop group DRUG

discontinue antiviral treatment

Also known as: discontinue antiviral treatment

Treatment Arm A

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (9)

Kyungpook National University Hospital

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung-Hee University Hospital

Seoul, South Korea

Location

Samsung Medical center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young-Suk Lim, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 4, 2021
• Study Start: September 1, 2021
• Primary Completion: August 19, 2024
• Study Completion: January 31, 2026
• Last Updated: October 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)