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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Clinicaltrials.gov identifier NCT03933384

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted October 8, 2020

Study Description

Brief summary:

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

  • Condition or Disease:Hepatitis B
    Viral Hepatitis
  • Intervention/Treatment: Drug: Tenofovir alafenamide
    Drug: Entecavir
  • Phase: Phase 4
Detailed Description

With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 420 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: The eligible chronic hepatitis B patients are randomly assigned (1:1) to receive once-daily oral doses of tenofovir alafenamide 25 mg or entecavir 0.5mg.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2025
Arms and interventions
Arm Intervention/treatment
Active Comparator: Tenofovir alafenamide group
Study subjects will receive tenofovir alafenamide 25 mg/tab once daily for 3 years (144 weeks).
Drug: Tenofovir alafenamide
Tenofovir alafenamide 25mg/tab once daily
Active Comparator: Entecavir group
Study subjects will receive entecavir 0.5 mg/tab once daily for 3 years (144 weeks).
Drug: Entecavir
Entecavir 0.5mg/tab once daily
Outcome Measures
  • Primary Outcome Measures: 1. HBV viral suppression [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    proportion of patients with hepatitis B virus(HBV) -DNA suppression
  • 2. Renal safety: Change of estimated glomerular filtration rate [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    Change of estimated glomerular filtration rate
  • Secondary Outcome Measures: 1. Normalization alanine aminotransferase (ALT) [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    proportion of patients with ALT normalization
  • 2. HBsAg loss [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    proportion of patients with HBsAg loss
  • 3. HBeAg loss [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    proportion of patients with HBeAg loss
  • 4. Bone mineral density [ Time Frame: After 48-week therapy of Tenofovir alafenamide or entecavir ]
    change of bone mineral density
Eligibility Criteria
  • Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Teng-Yu Lee, MD, PhD 886-4-23592525 ext 3301 tylee@vghtc.gov.tw

Contact: Hsin-Ju Tsai, MD 886-4-23592525 ext 3301 a9194024@hotmail.com

Locations

Taiwan
Taichung Veterans General Hospital
Taichung

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

Study Chair: Teng-Yu Lee, MD, PhD Taichung Veterans General Hospital

More Information