HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance

Last updated: November 3, 2014
Sponsor: Pusan National University Hospital
Overall Status: Trial Status Unknown

Phase

3

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT01769833
ML25659
  • Ages > 18
  • All Genders

Study Summary

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent

  • Age over 20 years

  • HBeAg-positive CHB patients

  • Patients treated with all available nucleoside analogue monotherapy or combination inKorea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovircombination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who haveundetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml )Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102IU/ml

  • Negative urine or serum pregnancy test (for women of childbearing potential)documented within the 24-hour period prior to the first dose of test drug.Additionally, all fertile males with partners of childbearing age and females must beusing reliable contraception during the study and for 3 months after treatmentcompletion.

  • Obtaining written informed consent form

Exclusion

Exclusion Criteria:

  • Decompensated cirrhosis or other contraindications to interferon alfa 2a therapyfollowing local label.

  • Concomitant or prior use of telbivudine.

  • Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis Cvirus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab.

  • Diagnosed hepatic cellular carcinoma

  • Any evidence of decompensated liver disease (Childs B-C)

  • History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxinexposures, thalassemia).

  • Women with ongoing pregnancy or who are breast feeding.

  • Evidence of alcohol and/or drug abuse within one year of entry.

  • History of major organ transplantation with an existing functional graft.

  • Inability or unwillingness to provide informed consent or abide by the requirements ofthe study.

  • History or other evidence of severe illness or any other conditions which would makethe patient, in the opinion of the investigator, unsuitable for the study.

  • Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.

  • patients having hypersensitivities for peginterferon alfa-2a or NAs

Study Design

Total Participants: 144
Study Start date:
May 01, 2013
Estimated Completion Date:
May 31, 2016

Study Description

Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion.

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.

Connect with a study center

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

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