Chronic Hepatitis b, Cirrhosis Due to Hepatitis B
Conditions
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.
Interventions
Patients would take tenofovir alafenamide fumarate, 25mg，once per day
DRUGEntecavir or Tenofovir disoproxil fumarate
Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | 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 | 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 | 0 week, 48 week, 96 week, 144 week. | Bone mineral density in lumbar spine and hip were tested after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in symptoms | 0 week, 12 week, 24 week, 48 week, 72 week, 96 week, 120 week, 144 week | Symptoms would be evaluated at each time point |
| The changes of HBeAg | 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. |
| The changes of alanine aminotransferase | 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. |
| Differences in body weight | 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 |
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | 12 week, 48 week, 72 week, 96 week, 120 week, 144 week | Hepatitis b virus DNA would be tested at 6 time points. |
| Differences in osmotic pressure | 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 |
| Differences in blood calcium and phosphorus | 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 |
| Differences in blood lipid | 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 |
| Differences in serum creatine kinase | 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 |
| Differences in proteinuria, albuminuria and urinary β2-microglobulin | 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 |
| The changes of HBsAg | 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. |
| The changes of the degree of liver fibrosis | 0 week, 48 week, 96 week, 144 week. | Fibroscan would be conducted once every 48 weeks |
Countries
China
Contacts
Primary ContactYuehua Huang, doctorate
Backup ContactGuofen Zeng, masterate
Outcome results
None listed