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Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT03933384
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Teng-Yu Lee, Taichung Veterans General Hospital

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 Intervention/treatment Phase
Hepatitis B Viral Hepatitis Drug: Tenofovir alafenamide Drug: Entecavir 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).

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Study Type : Interventional  (Clinical Trial)
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 19, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025


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
Other Name: Vemlidy

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
Other Name: Baraclude




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933384


Contacts
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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
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Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan
Contact: Teng-Yu Lee, MD, PhD    886-4-23592525 ext 3301    tylee@vghtc.gov.tw   
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
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Study Chair: Teng-Yu Lee, MD, PhD Taichung Veterans General Hospital

Publications of Results:

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Responsible Party: Teng-Yu Lee, Principal Investigator, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03933384     History of Changes
Other Study ID Numbers: CF18341A
106DHA0500150 ( Other Grant/Funding Number: Taichung Veterans General Hospital, Taiwan )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Teng-Yu Lee, Taichung Veterans General Hospital:
Hepatitis B
Viral Hepatitis
Tenofovir alafenamide
Entecavir
Additional relevant MeSH terms:
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Entecavir
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents