Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.

Detailed Description
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This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.

Official Title
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Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose & Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients

Conditions
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Hepatitis B Virus

Intervention / Treatment
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* Biological: Human Serum Albumin/interferon alpha2b fusion protein
* Biological: Pegasys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBV patients who have positive HBeAg or HBeAb Must be healthy males or females between 18 to 60 years old Must have a body mass index (BMI) of 18 to 30 kg/m2 HBV DNA≥2000 IU/mL ALT≥1.3 ULN and ≤10 ULN Exclusion Criteria: Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time. Participated in other clinical trials within a month. Allergic to interferon. T-Bil ≥2 ULN. ALB<35g/L. PT≥4s. Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab. Organ transplant patients, except cornea or hair transplantation. Other hepatopathy exclude NAFLD . Drug addiction or alcohol dependence. Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history. Serious retinal disease. Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder. Autoimmune disease. Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure. WBC<3×109/L or ANC<1.5 ×109/L or PLT<90 ×109/L or HGB<ULN. HCC or AFP>100ng/mL. Chronic kidney disease or sCr>ULN. Lactating women or pregnancy. Cardiovascular and cerebrovascular events within 6 months. Neurological or psychiatric disease or family history.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 alpha2b<br>Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks. | Biological: Human Serum Albumin/interferon alpha2b fusion protein<br>* In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.<br>|
| Active Comparator: Pegasys<br>Pegasys 180 mcg, once per week | Biological: Pegasys<br>* In comparator group, each subject will recieve 180mcg once per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment | HBV DNA | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment | HBV DNA | 4 weeks and 17 weeks | 
| the recovery rates of ALT after treatment | ALT | 17 weeks | 
| the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment | HBsAg/HBeAg | 17 weeks | 
| the rates of HBsAg decrease from baseline after treatment | HBsAg | 17 weeks |