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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Biological: Human Serum ALbumin/interferon alpha2a
* Biological: Pegasys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Serum Albumin/interferon alpha2a<br>Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C. | Biological: Human Serum ALbumin/interferon alpha2a<br>* 600,750 or 900 mcg dosing every 2 weeks<br>|
| Active Comparator: Pegasys<br>Peginteferon 180 mcg multiple dose S.C. | Biological: Pegasys<br>* 180 mcg dosing every week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of HBV DNA |  | 18 weeks | 
| AUCss |  | 18 weeks | 
| Css_av |  | 18 weeks | 
| Css_min |  | 18 weeks | 
| Css-max |  | 18 weeks | 
| T1/2 |  | 18 weeks | 
| Tmax |  | 18 weeks |