Lead Sponsor

Novartis Pharmaceuticals

Collaborators

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
•Chronic HBV infection (serum HBsAg detectable for \> 6 months)
•Serum HBeAg positive with HBV DNA \>106copies/mL (or \>200,000 IU/mL)
•Serum ALT must be \> 2 x ULN but below 10 x ULN

•Steroid treatment or immunosuppression 3 months prior to entry.
•Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
•Hb\< 10g/dL or, and ANC \< 750/mm3 or , and platelet count \< 75,000 mm3 .
•Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
•Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
•Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
•History of hypothyroidism or current treatment for thyroid disease.
•Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma

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