Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Pusan National University Hospital
Busan,
Korea, Republic ofSite Not Available
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