Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

Study Overview
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Brief Summary
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This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.

Official Title
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A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: albinterferon alfa-2b
* Drug: albinterferon alfa-2b
* Drug: albinterferon alfa-2b
* Drug: albinterferon alfa-2b
* Drug: Pegasys®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Group 1 ABF656 900ug Q2w<br> | Drug: albinterferon alfa-2b<br> <br> |
| Experimental: Group 2 ABF656 900ug Q4w<br> | Drug: albinterferon alfa-2b<br> <br> |
| Experimental: Group 3 AB656 1200ug Q4w<br> | Drug: albinterferon alfa-2b<br> <br> |
| Experimental: Group 4 ABF656 1500ug Q4w<br> | Drug: albinterferon alfa-2b<br> <br> |
| Active Comparator: Group 5 Pegasys® 180µg qw<br> | Drug: Pegasys®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b |  | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B,, Chronic,, Hepatitis B e Antigens positive