Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related L… (NCT03957629) | Clinical Trial Compass
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Optimized Treatment of Peginterferon Alfa 2a in Treatment Experienced Patients With HBV Related Liver Fibrosis
China186 participantsStarted 2019-11-06
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.)；
What they're measuring
1
Ratio of regression of fibrosis
Timeframe: 48 weeks; 96 weeks
Trial details
NCT IDNCT03957629
SponsorThird Affiliated Hospital, Sun Yat-Sen University