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Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B (ADAPT)

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ClinicalTrials.gov Identifier: NCT04782375
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Young-Suk Lim, Asan Medical Center

Study Description
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Brief Summary:
Multicenter, Open-label, Randomized Controlled 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 (-)

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Other: Stop group Drug: Continue group Phase 4

Detailed Description:

This clinical trial is a multicenter, open label, randomized controlled study to compare the short-term clinical outcome between stopping and continuing antiviral treatment in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-) Approximately 280 subjects meeting eligibility criteria will be enrolled and randomized (1:1) to Treatment Arm (A) or Treatment Arm (B), as below;

  • Treatment Arm A: 140 subjects, discontinue antiviral treatment (stop group)
  • Treatment Arm B: 140 subjects, continue antiviral treatment (continue group) This study was designed to randomly assign treatment groups to subjects in order to prevent biases that may be intervened, and to increase comparability between the groups. Since post-treatment HBsAg titer could affect the clinical outcome in the eligible subjects, randomization will be stratified by post-treatment HBsAg titer (≥100 IU/mL or <100 IU/mL) at screening at a 1:1 ratio by using centralized stratified block randomization.

Both groups (i.e. Treatment Arm A and B) are scheduled to be followed up to 2 years. Patients in the Treatment Arm A (stop group) were 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) progression to liver cirrhosis, or 3) development of hepatocellular carcinoma.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multicenter, Open-label, Randomized Controlled Trial to Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B (ADAPT)
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm A
discontinue antiviral treatment
 Other: Stop group
discontinue antiviral treatment
Other Name: discontinue antiviral treatment
Active Comparator: Treatment Arm B
continue antiviral treatment
 Drug: Continue group
continue antiviral treatment
Other Name: continue antiviral treatment


Outcome Measures
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Primary Outcome Measures :
  1. virological relapse [ Time Frame: Change from baseline in HBV DNA result at 2year ]
    Proportion of virological relapse defined as HBV DNA ≥2,000 IU/mL


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to study entry
  2. Age ≥19 years and ≤55 years at the time of screening
  3. At least once, confirmation HBeAg(+) prior study enrollment
  4. HBsAg titer <1,000 IU/mL at the time of screening
  5. Antiviral treatment continued at least 2 years after HBeAg seroclearance (HBeAg (-) at the time of screening)
  6. Undetectable HBV DNA level at the time of screening
  7. Serum ALT level <40 IU/mL at the time of screening
  8. Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation)
  9. Ability to comply with all study requirements including 2-month visit interval

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, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy, variceal hemorrhage, 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 if AFP shows decreasing trend and there is no evidence of HCC by dynamic CT or MRI)
  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 randomization, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782375


Contacts
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Contact: Young-Suk Lim, PhD 82-2-3010-3190 limys@amc.seoul.kr

Locations
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Korea, Republic of
Kyungpook National University Hospital Not yet recruiting
Daegu, Korea, Republic of
Contact: Soo Young Park         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Young-Suk Lim, PhD         
Chung-Ang University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyung Joon Kim         
Konkuk University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: So Young Kwon         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ji Hoon Kim         
Kyung-Hee University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Gi-Ae Kim         
Samsung Medical center Not yet recruiting
Seoul, Korea, Republic of
Contact: Wonseok Kang, PhD         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeong Hoon Lee         
Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeong Won Jang         
Ulsan University Hospital Not yet recruiting
Ulsan, Korea, Republic of
Contact: Neung-Hwa Park         
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young-Suk Lim, PhD Asan Medical Center
More Information
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Responsible Party: Young-Suk Lim, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04782375    
Other Study ID Numbers: AMC 2021-0135
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents