Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
NCT ID: NCT04496882
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
260 participants
INTERVENTIONAL
2020-09-09
2023-12-31
Brief Summary
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Chronic hepatitis B patients receiving oral antiviral therapy (entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\]) for at least 2 years, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF.
The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.
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Detailed Description
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This is a single-arm prospective clinical trial to enroll patients who discontinued entecavir (ETV) and tenofovir disoproxil fumarate (TDF) and experienced a clinical hepatitis flare up. They can be retreated with TAF for 48 weeks without postponing a 3-month observation period for alanine aminotransferase (ALT) level. The virological control, ALT level recovery, and changes in liver fibrosis, hepatitis B surface antigen, hepatitis B core-associated antigen, and renal function will be observed during retreatment. In addition, a group of patients with the same characteristics who received retreatment with entecavir or TDF will be collected as a control group for comparison. We believe this study can help us understand the clinical benefits of switching to TAF for retreatment after hepatitis flare in patients to discontinue oral antiviral agents.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Switching therapy cohort
single arm, open label Patients will receive Vemlidy (tenofovir alafenamide, TAF) 25mg, daily for 48 weeks
Vemlidy
25mg Tenofovir Alafenamide
Historical continuing therapy cohort
By retrospectively review medical records, The patients continued the original regimen (ETV, TDF) for retreatment (within 3 months of clinical relapse)
No interventions assigned to this group
Interventions
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Vemlidy
25mg Tenofovir Alafenamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. After NUC discontinuation, patients had a clinical relapse (HBV DNA \> 2000 IU/mL, and ALT \> 2x ULN)
3. The retreatment regimen switches to TAF (within 3 months of clinical relapse)
B. Historical continuing therapy cohort
1. Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 2 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive patients achieving HBeAg seroclearance, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieving undetectable HBV DNA for more than 1 year(on 3 occasions, 6 months apart)
2. After NUC discontinuation, patients had a clinical relapse (HBV DNA \> 2000 IU/mL, and ALT \> 2x ULN)
3. The patients continued the original regimen (ETV, TDF) for retreatment (within 3 months of clinical relapse)
Exclusion Criteria
2. Patients who have HCV, HDV or HIV co-infection
3. Patients who discontinue lamivudine, adefovir, or telbivudine therapy
4. Patients with liver cirrhosis by ultrasonography and clinical diagnosis
20 Years
99 Years
ALL
No
Sponsors
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National Taiwan University Hospital, Yun-Lin Branch
OTHER
Taipei City Hospital
OTHER_GOV
Chiayi Christian Hospital
OTHER
Dalin Tzu Chi General Hospital
OTHER
E-DA Hospital
OTHER
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
OTHER
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Tung-Hung Su, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Buddhist Tzu Chi General Hospital, Da-Lin Branch
Chiayi City, , Taiwan
Chia-Yi Christian Hospital
Chiayi City, , Taiwan
National Taiwan University Hospital, Yun-Lin branch
Douliu, , Taiwan
E-da hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Buddhist Tzu-Chi General Hospital Taipei Branch
Taipei, , Taiwan
Taipei City Hospital, Renai Branch
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201911095MIPD
Identifier Type: -
Identifier Source: org_study_id
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