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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04496882
Other study ID # 201911095MIPD
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 9, 2020
Est. completion date December 31, 2023

Study information

Verified date August 2021
Source National Taiwan University Hospital
Contact Tung-Hung Su, MD, PhD
Phone 886972651694
Email tunghungsu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We will conduct a phase 4, multicenter, open-label trial at 7 academic centers in Taiwan. 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 99 Years
Eligibility Inclusion Criteria A. Switching 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 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 1. Patients who do not fulfill the discontinuation 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

Study Design


Intervention

Drug:
Vemlidy
25mg Tenofovir Alafenamide

Locations

Country Name City State
Taiwan 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
Taiwan Buddhist Tzu-Chi General Hospital Taipei Branch Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei City Hospital, Renai Branch Taipei

Sponsors (7)

Lead Sponsor Collaborator
National Taiwan University Hospital Chiayi Christian Hospital, Dalin Tzu Chi General Hospital, E-DA Hospital, National Taiwan University Hospital, Yun-Lin Branch, Taipei City Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Rate of ALT normalization (ALT < 40 U/L) after retreatment We will calculate the rate of ALT normalization (ALT < 40 U/L) after retreatment 48 weeks
Secondary Rate of HBsAg change after retreatment compared with baseline We will investigate the rate of HBsAg change after retreatment compared with the baseline HBsAg 48 weeks
Secondary Rate of HBcrAg change after retreatment compared with baseline We will investigate the rate of hepatitis B core-related antigen (HBcrAg) change after retreatment compared with baseline HBcrAg 48 weeks
Secondary Rate of M2BPGi level change after retreatment compared with baseline We will investigate the rate of Mac-2 binding protein glycosylation isomer (M2BPGi) level change after retreatment compared with baseline M2BPGi level 48 weeks
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