search
Back to results

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

Primary Purpose

Chronic Hepatitis b, Cirrhosis Due to Hepatitis B

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tenofovir alafenamide fumarate
Entecavir or Tenofovir disoproxil fumarate
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

switch to tenofovir alafenamide fumarate

Continue with the original regimen

Arm Description

Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day

Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day

Outcomes

Primary Outcome Measures

Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment.
The changes of glomerular filtration rate
Glomerular filtration rate will be tested to know the changes after treatment
The changes of bone mineral density in lumbar spine and hip
Bone mineral density in lumbar spine and hip were tested after treatment

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2020
Last Updated
October 28, 2020
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT04501224
Brief Title
The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
Official Title
The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b, Cirrhosis Due to Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
switch to tenofovir alafenamide fumarate
Arm Type
Experimental
Arm Description
Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day
Arm Title
Continue with the original regimen
Arm Type
Active Comparator
Arm Description
Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day
Intervention Type
Drug
Intervention Name(s)
Tenofovir alafenamide fumarate
Other Intervention Name(s)
Vemlidy
Intervention Description
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
Intervention Type
Drug
Intervention Name(s)
Entecavir or Tenofovir disoproxil fumarate
Other Intervention Name(s)
Baraclude or Viread
Intervention Description
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
Primary Outcome Measure Information:
Title
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Description
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 24 week after treatment.
Time Frame
24 week
Title
The changes of glomerular filtration rate
Description
Glomerular filtration rate will be tested to know the changes after treatment
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
The changes of bone mineral density in lumbar spine and hip
Description
Bone mineral density in lumbar spine and hip were tested after treatment
Time Frame
0 week, 48 week, 96 week, 144 week.
Secondary Outcome Measure Information:
Title
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Description
Hepatitis b virus DNA would be tested at 6 time points.
Time Frame
12 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
The changes of HBsAg
Description
The levels of HBsAg were tested at each time point.
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
The changes of the degree of liver fibrosis
Description
Fibroscan would be conducted once every 48 weeks
Time Frame
0 week, 48 week, 96 week, 144 week.
Title
Differences in symptoms
Description
Symptoms would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
The changes of HBeAg
Description
The levels of HBeAg were tested at each time point.
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
The changes of alanine aminotransferase
Description
The levels of alanine aminotransferase were tested at each time point.
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in body weight
Description
Body weight would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in proteinuria, albuminuria and urinary β2-microglobulin
Description
Proteinuria, albuminuria and urinary β2-microglobulin would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in osmotic pressure
Description
The levels of osmotic pressure would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in blood calcium and phosphorus
Description
The levels of blood calcium and phosphorus would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in blood lipid
Description
The levels of blood lipid would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Title
Differences in serum creatine kinase
Description
The levels of creatine kinase would be evaluated at each time point
Time Frame
0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehua Huang, doctorate
Phone
0086-13822232795
Email
huangyh53@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guofen Zeng, masterate
Phone
0086-13570305907
Email
zengguofen06@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuehua Huang, doctorate
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guofen Zeng, Master
Phone
86-13570305907
Email
zenggfen@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs