Hepatitis B Clinical Trial
Official title:
An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis.
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.
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.
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