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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    186
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 24 February 2022
liver cancer
cancer
tenofovir
hepatitis
fumarate
interferon
liver disease
cirrhosis
hepatitis b surface antigen
hbsag
hepatitis b antigen
fibrosis
hepatic fibrosis
fibroscan
peginterferon

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.

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.

Details
Condition Hepatitis B, Liver Fibrosis
Treatment Tenofovir disoproxil fumarate, PEG-Interferon alfa 2a
Clinical Study IdentifierNCT03957629
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year
Receiving treatment of nucleoside/nucleotide analogues at least one year before recruited
Age from 18 to 55 years old
Normal liver function(ALT<ULN,AST<ULN and TBil<ULN)
Undetectable hepatitis b virus DNA or less than 100IU/ml
LSM between 6 and 12 kpa measured by fibroscan
Liver ultrasound: normal or echo thickening, and portal vein diameter 12mm

Exclusion Criteria

Decompensated cirrhosis, hepatocellular carcinoma or other malignancy
Pregnancy, lactation or female has plan of pregnancy within 18 months
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.)
Accompanied with human immunodeficiency virus infection or congenital immune deficiency diseases
Accompanied with severe diabetes, autoimmune diseases etc. and other important organ dysfunctions
Patients who fail to comply with this research arrangement and sign an informed consent form
Patients can not follow-up
Investigator considering inappropriate
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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