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

Last updated: May 20, 2019
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Scar Tissue

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT03920605
PL5
  • Ages 15-55
  • All Genders

Study Summary

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b 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 investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with HBV related liver fibrosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Age from 18 to 55 years old;

  3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosislever of 7 to 14 kpa from fibroscan;

  4. Portal vein diameter ≤ 12 mm from liver ultrasound;

  5. Receiving treatment of nucleoside/nucleotide analogues at the past one year;

  6. Normal liver function;

  7. Undetectable hepatitis b virus DNA.

Exclusion

Exclusion Criteria:

  1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;

  2. Pregnancy or lactation;

  3. Other active liver diseases;

  4. Human immunodeficiency virus infection or congenital immune deficiency diseases;

  5. Severe diabetes, autoimmune diseases;

  6. Other important organ dysfunctions;

  7. Patients can not follow-up;

  8. Investigator considering inappropriate.

Study Design

Total Participants: 100
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2021

Study Description

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment experienced patients with HBV related liver fibrosis.

Connect with a study center

  • Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

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