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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Affiliated Hospital, Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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