Phase
Condition
Hepatitis
Hepatitis B
Liver Disorders
Treatment
N/AClinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients 18-55 years of age
Chronic HBeAg negative hepatitis B
Liver disease consistent with chronic hepatitis documented by liver biopsy within 18months prior to enrollment
Participation in study ML18253.
Exclusion
Exclusion Criteria:
Interferon-based or any systemic anti-HBV therapy </= 12 months prior to first dose ofstudy drug
Antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to firstdose of study drug
Nonresponders to previous interferon therapy and resistant to lamivudine
Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
Hepatocellular cancer
Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
History or evidence of medical condition associated with chronic liver disease otherthan HBV
Study Design
Connect with a study center
Bologna, 40138
ItalySite Not Available
Brescia, 25125
ItalySite Not Available
Milano, 20122
ItalySite Not Available
Parma, 43100
ItalySite Not Available
Reggio Emilia, 42100
ItalySite Not Available
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