Chronic hepatitis B
Conditions
Interventions
investigational group:Novaferon, intramuscular injection
control group:interferon alpha 2b, intramuscular injection
Sponsors
The XiangYa Hospital, ZhongNan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Chronic hepatitis B participate in this clinical trial voluntarily and may benefit from this trial; 2. Diagnosis of Chronic hepatitis B based on the guidelines of Chronic hepatitis B(2005). Patients are HBeAg -positive; 3. Patients who have a serum HBV DNA level ranges between 105 cps/ml and 109 cps/ml; 4. 18~60 years of age, regardless of gender; 5. Female: Women of childbearing potential must have a negative serum or urine pregnancy test at screening, and use an approved contraception. Male: Must be surgically sterile or compliant with an adequate contraception during, and for 3 months after the treatment; 6. The signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of interferon or antiviral use within 6 months before signing informed consent form; 2. Patients with known allergy to interferon-adrugs; 3. Patients who had taken other investigational products within 3 months preceding the informed consent was signed; 4. Patients who are receiving other antiviral therapies at the same time; 5. Drug addiction or alcohol dependence; 6.Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg;HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT;HBsAg; | — |
Countries
China
Contacts
Public ContactDeming Tan
Outcome results
None listed