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NCT Number: NCT04496882

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue

We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan.

Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 1 year, 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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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Buddhist Tzu Chi General Hospital, Da-Lin Branch, Chiayi City, Taiwan

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About this study

Tenofovir alafenamide (TAF) is a new generation of oral antiviral drugs with similar antiviral activities to tenofovir disoproxil fumarate (TDF) and reduces the adverse effects of nephrotoxicity and bone mineral density reduction. This drug has already been reimbursed by National Health Insurance, and can be used for the treatment of patients with chronic hepatitis B.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A. Switching therapy cohort

  • Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1)HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
  • After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and ALT > 2x ULN)
  • The retreatment regimen switches to TAF (within 3.3 months of clinical relapse)

B. Historical continuing therapy cohort

  • Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA <20 IU/mL) for more than 1 year
  • After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and ALT > 2x ULN)
  • The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse)

Exclusion criteria

  • Patients who do not fulfill the discontinuation criteria
  • Patients who have HCV, HDV or HIV co-infection
  • Patients who discontinue lamivudine, adefovir, or telbivudine therapy
  • Patients with liver cirrhosis by ultrasonography and clinical diagnosis

Treatment and study plan

Vemlidy

Drug

25mg Tenofovir Alafenamide

Other names: Tenofovir Alafenamide (TAF)

Primary outcomes

  1. Rate of virological remission (HBV DNA <20 IU/mL)

    Time frame: 48 weeks

    We will calculate the rate of virological remission (HBV DNA <20 IU/mL) after retreatment

Secondary outcomes

  1. Rate of ALT normalization (ALT < 40 U/L) after retreatment

    Time frame: 48 weeks

    We will calculate the rate of ALT normalization (ALT < 40 U/L) after retreatment

  2. Rate of HBsAg change after retreatment compared with baseline

    Time frame: 48 weeks

    We will investigate the rate of HBsAg change after retreatment compared with the baseline HBsAg

  3. Rate of HBcrAg change after retreatment compared with baseline

    Time frame: 48 weeks

    We will investigate the rate of hepatitis B core-related antigen (HBcrAg) change after retreatment compared with baseline HBcrAg

  4. Rate of M2BPGi level change after retreatment compared with baseline

    Time frame: 48 weeks

    We will investigate the rate of Mac-2 binding protein glycosylation isomer (M2BPGi) level change after retreatment compared with baseline M2BPGi level

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Chiayi Christian Hospital
  • Dalin Tzu Chi General Hospital
  • E-DA Hospital
  • National Taiwan University Hospital Hsin-Chu Branch
  • National Taiwan University Hospital, Yun-Lin Branch
  • Taipei City Hospital
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Registry information

Official study title

The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy

Acronym: CHANGE

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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