Overview

Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis

Status:
Recruiting

Trial end date:
2023-07-30

Target enrollment:
0

Participant gender:
All

Summary

Compared to TDF, peginterferon alfa 2a may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to compare the effectiveness and safety between the combination therapy of TDF and peg-IFN with TDF alone in NAs experienced patients with HBV related liver fibrosis. Especially the improvement of liver fibrosis and the occurrence of long-term end-stage liver disease such as cirrhosis, liver cancer, etc.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Third Affiliated Hospital, Sun Yat-Sen University

Treatments:

Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Tenofovir

Criteria

Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;

2. Receiving treatment of nucleoside/nucleotide analogues at least one year before
recruited;

3. Age from 18 to 55 years old;

4. Normal liver function(ALT
5. Undetectable hepatitis b virus DNA or less than 100IU/ml.

6. LSM between 6 and 12 kpa measured by fibroscan;

7. Liver ultrasound: normal or echo thickening, and portal vein diameter ≤ 12mm.

Exclusion Criteria:

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;

2. Pregnancy, lactation or female has plan of pregnancy within 18 months;

3. Accompanied with other active liver diseases(HAV, HCV, HDV, HEV, autoimmune liver
disease, drug-induced liver injury, alcoholic liver disease, genetic metabolic liver
disease, etc.)；

4. Accompanied with human immunodeficiency virus infection or congenital immune
deficiency diseases;

5. Accompanied with severe diabetes, autoimmune diseases etc. and other important organ
dysfunctions;

6. Patients who fail to comply with this research arrangement and sign an informed
consent form

7. Patients can not follow-up;

8. Investigator considering inappropriate.