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

Chronic Hepatitis b Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501224
• Other study ID #: TAF
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2020
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Yuehua Huang, doctorate
• Phone: 0086-13822232795
• Email: huangyh53[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2024
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Cirrhosis Due to Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Tenofovir alafenamide fumarate
Patients would take tenofovir alafenamide fumarate, 25mg,once per day
• Entecavir or Tenofovir disoproxil fumarate
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 week
Primary	The changes of glomerular filtration rate	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
Primary	The changes of bone mineral density in lumbar spine and hip	Bone mineral density in lumbar spine and hip were tested after treatment	0 week, 48 week, 96 week, 144 week.
Secondary	Ratio of patients with undetectable hepatitis b virus DNA after treatment	Hepatitis b virus DNA would be tested at 6 time points.	12 week, 48 week, 72 week, 96 week, 120 week, 144 week
Secondary	The changes of HBsAg	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
Secondary	The changes of the degree of liver fibrosis	Fibroscan would be conducted once every 48 weeks	0 week, 48 week, 96 week, 144 week.
Secondary	Differences in symptoms	Symptoms would be evaluated at each time point	0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Secondary	The changes of HBeAg	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
Secondary	The changes of alanine aminotransferase	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
Secondary	Differences in body weight	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
Secondary	Differences in proteinuria, albuminuria and urinary ß2-microglobulin	Proteinuria, albuminuria and urinary ß2-microglobulin would be evaluated at each time point	0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week
Secondary	Differences in osmotic pressure	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
Secondary	Differences in blood calcium and phosphorus	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
Secondary	Differences in blood lipid	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
Secondary	Differences in serum creatine kinase	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