Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients

Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients

This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.

Inclusion Criteria:

• Male or female, aged 18-75 years
• Chronic HBV infection (serum HBsAg detectable for > 6 months)
• Serum HBeAg positive with HBV DNA >10^6copies/mL (or >20,000 IU/mL),orSerum HBeAg negative with HBV DNA >10^5copies/mL (or >2,000 IU/mL)
• Serum ALT must be > 2 x ULN but below 10 x ULN

Exclusion Criteria:

• Steroid treatment or immunosuppression 3 months prior to entry.
• Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
• Active lung disease or history of interstitial lung disease.
• Hb< LLN or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 ,or WBC<3000/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 thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply