NCT04496882Active, not recruitingPhase 4
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 26 Jul 2020
- Start date
- 9 Sept 2020
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT04496882
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 260
- From 9 Sept 2020 to the primary completion date, 1 Jan 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who discontinue lamivudine, adefovir, or telbivudine therapy
Other illness
- Patients who have HCV, HDV or HIV co-infection
Other
- Patients who do not fulfill the discontinuation criteria
- Patients with liver cirrhosis by ultrasonography and clinical diagnosis
Who the study is looking for
- 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)
- 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)
Age in the registry: 20 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chia-Yi Christian Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Buddhist Tzu Chi General Hospital, Da-Lin Branch Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| National Taiwan University Hospital Yun-Lin Branch Coordinator of this site? Confirm its status | Douliu | Taiwan | Unknown status |
| National Taiwan University Hospital Hsin Chu Branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Buddhist Tzu Chi General Hospital, Taipei branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei City Hospital, RENAI Branch Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.