MedDataX Logo

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

NCT ID: NCT04501224

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis b Cirrhosis Due to Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

switch to tenofovir alafenamide fumarate

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

Group Type EXPERIMENTAL

Tenofovir alafenamide fumarate

Intervention Type DRUG

Patients would take tenofovir alafenamide fumarate, 25mg，once per day

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

Group Type ACTIVE_COMPARATOR

Entecavir or Tenofovir disoproxil fumarate

Intervention Type DRUG

Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tenofovir alafenamide fumarate

Patients would take tenofovir alafenamide fumarate, 25mg，once per day

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vemlidy Baraclude or Viread

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yuehua Huang

Laboratory director of hepatology#Deputy director of infection

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuehua Huang, doctorate

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuehua Huang, doctorate

Role: CONTACT

[email protected]
0086-13822232795

Guofen Zeng, masterate

Role: CONTACT

[email protected]
0086-13570305907

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guofen Zeng, Master

Role: primary

[email protected]
86-13570305907

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAF

Identifier Type: -

Identifier Source: org_study_id