Status:
UNKNOWN
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital, Yun-Lin Branch
Taipei City Hospital
Conditions:
Chronic Hepatitis b
Hepatitis B Reactivation
Eligibility:
All Genders
20-99 years
Phase:
PHASE4
Brief 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 fumara...
Detailed 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 b...
Eligibility Criteria
Inclusion
- Inclusion Criteria A. Switching therapy cohort
- 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)
- 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 months of clinical relapse)
- B. Historical continuing therapy cohort
- 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)
- 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 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
Exclusion
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04496882
Start Date
September 9 2020
End Date
December 31 2023
Last Update
August 5 2021
Active Locations (7)
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1
Buddhist Tzu Chi General Hospital, Da-Lin Branch
Chiayi City, Taiwan
2
Chia-Yi Christian Hospital
Chiayi City, Taiwan
3
National Taiwan University Hospital, Yun-Lin branch
Douliu, Taiwan
4
E-da hospital
Kaohsiung City, Taiwan