NCT03933384 Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
| NCT ID | NCT03933384 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2019-08-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2019-08-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.
Eligibility Criteria
Inclusion Criteria: 1. Patients more than 20 years old 2. Chronic hepatitis B patients 3. Patients who were indicated for hepatitis B virus antiviral therapy Exclusion Criteria: 1. Decompensated liver disease (Child-Pugh B \&C) 2. End stage renal disease (eGRF \< 15 ml/min/1.73m2) 3. Prior use of nucleot(s)ide analogues for chronic hepatitis B 4. Prior use of interferon for chronic hepatitis B within six months 5. Known history of human immunodeficiency virus or hepatitis C virus co-infection 6. Concurrent other uncontrolled malignancy 7. Women in pregnancy or lactation 8. Cannot conform to the study protocol of this study
Contact & Investigator
Teng-Yu Lee, MD, PhD
STUDY CHAIR
Taichung Veterans General Hospital
Frequently Asked Questions
Who can join the NCT03933384 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03933384 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03933384 currently recruiting?
Yes, NCT03933384 is actively recruiting participants. Contact the research team at tylee@vghtc.gov.tw for enrollment information.
Where is the NCT03933384 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT03933384 clinical trial?
NCT03933384 is sponsored by Taichung Veterans General Hospital. The principal investigator is Teng-Yu Lee, MD, PhD at Taichung Veterans General Hospital. The trial plans to enroll 140 participants.