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

Sun Yat-sen University

Status: Unknown

Conditions: Liver Fibrosis; Hepatitis B

Treatments: Drug: Tenofovir Disoproxil Fumarate; Drug: PEG-Interferon alfa 2a

Study type: Interventional

Funder types: Other

Identifiers

NCT03957629

PL7

Details and patient eligibility

About

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.

Full description

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.

Main purpose: Comparing the improvement rate of liver fibrosis. Secondary purpose: Comparing the incidence of adverse events. Comparing the incidence of cirrhosis, hepatocellular carcinoma, and liver failure.

Comparing the rates of HBsAg and HBeAg serological conversion.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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<ULN,AST<ULN and TBil<ULN).
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

186 participants in 2 patient groups

TDF group

Active Comparator group

Description:

93 patients would receive treatment of oral medication of tenofovir disoproxil fumarate (TDF) 300mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Combination group

Active Comparator group

Description:

93 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg once per week and meanwhile oral medication of tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive oral medication of TDF 300 mg once per day from 49 to 96 weeks.

Treatment:

Drug: PEG-Interferon alfa 2a

Drug: Tenofovir Disoproxil Fumarate