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

NCT04496882 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 201911095MIPD
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Hepatitis b; Hepatitis B Reactivation

Keywords

HBV,clinical relapse,Vemlidy (TAF)

Outcome Measures

Primary Outcomes (1)

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

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

  48 weeks

Secondary Outcomes (4)

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

  48 weeks

• Rate of HBsAg change after retreatment compared with baseline

  48 weeks

• Rate of HBcrAg change after retreatment compared with baseline

  48 weeks

• Rate of M2BPGi level change after retreatment compared with baseline

  48 weeks

Study Arms (2)

Switching therapy cohort

EXPERIMENTAL

single arm, open label Patients will receive Vemlidy (tenofovir alafenamide, TAF) 25mg, daily for 48 weeks

Drug: Vemlidy

Historical continuing therapy cohort

NO INTERVENTION

By retrospectively review medical records, The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse)

Interventions

Vemlidy DRUG

25mg Tenofovir Alafenamide

Also known as: Tenofovir Alafenamide (TAF)

Switching therapy cohort

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

Buddhist Tzu Chi General Hospital, Da-Lin Branch

Chiayi City, Taiwan

Location

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Location

National Taiwan University Hospital, Yun-Lin branch

Douliu, Taiwan

Location

National Taiwan University Hospital ,Hsin-Chu Branch

Hsinchu, Taiwan

Location

E-da hospital

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Buddhist Tzu-Chi General Hospital Taipei Branch

Taipei, Taiwan

Location

Taipei City Hospital, Renai Branch

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide

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

• Tung-Hung Su, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 3, 2020
• Study Start: September 9, 2020
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (8)