Chronic Hepatitis bNCT04501224
The Efficacy and Safety of TAF vs Other NAs in Patients With LVL
A study testing Tenofovir alafenamide fumarate and Entecavir or Tenofovir disoproxil fumarate in people with Chronic Hepatitis b and Cirrhosis Due to Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis b, Cirrhosis Due to Hepatitis B
- What is being tested?
- Tenofovir alafenamide fumarate and Entecavir or Tenofovir disoproxil fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2020to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- Combination of Entecavir or Tenofovir disoproxil fumarate ;
- Interferon therapy within half a year;
- Entecavir (0.5mg qd) or Tenofovir disoproxil fumarate;
- Investigator considering inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Guofen Zeng, Master, 86-13570305907, zenggfen@mail.sysu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hepatitis b, Cirrhosis Due to Hepatitis B
- Being tested
- Tenofovir alafenamide fumarate, Entecavir or Tenofovir disoproxil fumarate
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir alafenamide fumarateDrug
Also called Vemlidy
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
Entecavir or Tenofovir disoproxil fumarateDrug
Also called Baraclude or Viread
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
| Study group | Role | What they receive |
|---|---|---|
| switch to tenofovir alafenamide fumarate | Experimental | Patients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day Receives: Drug: Tenofovir alafenamide fumarate |
| Continue with the original regimen | Active comparator | Patients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day Receives: Drug: Entecavir or Tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 week
The changes of glomerular filtration rate
Glomerular filtration rate will be tested to know the changes after treatment
Measured: 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
Bone mineral density in lumbar spine and hip were tested after treatment
Measured: 0 week, 48 week, 96 week, 144 week.
Secondary outcomes (12)
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested at 6 time points.
Measured: 12 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBsAg
The levels of HBsAg were tested at each time point.
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of the degree of liver fibrosis
Fibroscan would be conducted once every 48 weeks
Measured: 0 week, 48 week, 96 week, 144 week.
Differences in symptoms
Symptoms would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of HBeAg
The levels of HBeAg were tested at each time point.
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
The changes of alanine aminotransferase
The levels of alanine aminotransferase were tested at each time point.
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in body weight
Body weight would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in proteinuria, albuminuria and urinary β2-microglobulin
Proteinuria, albuminuria and urinary β2-microglobulin would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in osmotic pressure
The levels of osmotic pressure would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood calcium and phosphorus
The levels of blood calcium and phosphorus would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in blood lipid
The levels of blood lipid would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Differences in serum creatine kinase
The levels of creatine kinase would be evaluated at each time point
Measured: 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start3 Aug 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yuehua Huang, doctorate, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501224
- Sponsor's protocol ID
- TAF
- Status last verified
- Oct 2020
- First submitted
- 19 Jul 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04501224
- Acronym / sponsor ID
- TAF
- Conditions
- Chronic Hepatitis b, Cirrhosis Due to Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| switch to tenofovir alafenamide fumarate | Experimental | Drug: Tenofovir alafenamide fumaratePatients will switch to tenofovir alafenamide fumarate treatment, 25mg，once a day |
| Continue with the original regimen | Active comparator | Drug: Entecavir or Tenofovir disoproxil fumaratePatients will continue with the original regimen treatment, entecavir, 0.5mg once a day, or tenofovir disoproxil fumarate 300mg once a day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir alafenamide fumarateAlso: VemlidyPatients would take tenofovir alafenamide fumarate, 25mg，once per day | Drug | switch to tenofovir alafenamide fumarate |
| Entecavir or Tenofovir disoproxil fumarateAlso: Baraclude or VireadPatients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day | Drug | Continue with the original regimen |
Primary outcome
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.
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
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
12 secondary outcomes
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
The changes of HBsAg
Time frame: 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.
Differences in symptoms
Time frame: 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 changes of alanine aminotransferase
Time frame: 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
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
Differences in osmotic pressure
Time frame: 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
Differences in blood lipid
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuehua Huang, doctorate principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir alafenamide fumarate and Entecavir or Tenofovir disoproxil fumarate in people with Chronic Hepatitis b and Cirrhosis Due to Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuehua Huang, doctorate (0086-13822232795, huangyh53@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of patients with undetectable hepatitis b virus DNA after treatment (time frame: 24 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.