The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

October 28, 2020 updated by: Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University

The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV

Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who meet the inclusion and exclusion criteria will be enrolled into the research. The participants will voluntarily choose to enter the experimental group or the control group with full informed consent. The control group will continue with the original regimen, while the study group will switch to tenofovir alafenamide fumarate antiviral therapy. Each group will enroll 100 participants.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBsAg positive for over half a year;
  • Age from 18 to 80 years old;
  • Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate (300mg qd) for 48 weeks or more;
  • HBV DNA level was between 20IU/ ml-2000 IU /mL (COBAS, Taqman).

Exclusion Criteria:

  • Low-level viremia of HBV caused by non-standard medication;
  • serum total bilirubin is more than 2 times the upper limit of normal (ULN), or ALT or AST is more than 5ULN, or serum albumin is less than 30g/L;
  • Overlap with HAV, HCV, HDV, HEV or HIV infection;
  • Other liver disease: drug liver disease, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, etc.;
  • Decompensated cirrhosis or liver cancer;
  • Kidney damage, or autoimmune disease, or other organ failure;
  • Combination of Entecavir or Tenofovir disoproxil fumarate ;
  • Interferon therapy within half a year;
  • Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate;
  • Investigator considering inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: switch to tenofovir alafenamide fumarate
Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day
Drug: Tenofovir alafenamide fumarate
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
Other Names:
  • Vemlidy
Active Comparator: Continue with the original regimen
Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day
Drug: Entecavir or Tenofovir disoproxil fumarate
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
Other Names:
  • Baraclude or Viread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Time Frame: 24 week
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment.
24 week
The changes of glomerular filtration rate
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Glomerular filtration rate will be tested to know the changes after treatment
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of bone mineral density in lumbar spine and hip
Time Frame: 0 week, 48 week, 96 week, 144 week.
Bone mineral density in lumbar spine and hip were tested after treatment
0 week, 48 week, 96 week, 144 week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Time Frame: 12 week, 48 week, 72 week, 96 week, 120 week, 144 week
Hepatitis b virus DNA would be tested at 6 time points.
12 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBsAg
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of HBsAg were tested at each time point.
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of the degree of liver fibrosis
Time Frame: 0 week, 48 week, 96 week, 144 week.
Fibroscan would be conducted once every 48 weeks
0 week, 48 week, 96 week, 144 week.
Differences in symptoms
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Symptoms would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBeAg
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of HBeAg were tested at each time point.
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of alanine aminotransferase
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of alanine aminotransferase were tested at each time point.
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in body weight
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Body weight would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in proteinuria, albuminuria and urinary β2-microglobulin
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Proteinuria, albuminuria and urinary β2-microglobulin would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in osmotic pressure
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of osmotic pressure would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood calcium and phosphorus
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of blood calcium and phosphorus would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood lipid
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of blood lipid would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in serum creatine kinase
Time Frame: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The levels of creatine kinase would be evaluated at each time point
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Yuehua Huang, doctorate, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

July 19, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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