Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection

Korábbi kezelés

• For NAs treated patients: who have received standard treatment of interferon products within 6 months prior to screening.
• Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids.
• Evidence of liver compensation, including previous liver biopsy, imaging examination or clinical manifestations.
• Function organs transplant.
• Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day).
• Participated in other clinical trials 3 months prior to the screening.

Más betegség

• Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
• Liver diseases from other causes, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
• Diabetes mellitus or Poorly controlled Thyroid Diseases.
• Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions.
• Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
• Psychiatric and nervous system disorders, including history of psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
• Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias).
• Serious blood disorders (all kinds of anemia, hemophilia, etc.)
• Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
• Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
• Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
• Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
• Malignancies.
• Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs.
• Other conditions not suitable for study judged by investigators.

Laborértékek

• Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade.
• White blood cell count <3×10\^9/L; neutrophil count<1.5×10\^9/L; platelet count<90×10\^9/L; hemoglobin below the lower limit of normal; serum creatine kinase (CK) >3×ULN; blood phosphorus <0.8 mmol/L; serum creatinine (SCr) > 1×ULN.

Egyéb

• Evidence of hepatocellular carcinoma, or AFP>>50 ng/mL, or imaging examination revealed suspicious nodules in the liver.
• Women who are pregnant or lactating or to be pregnant during the study period.
• Unwilling to sign the informed consent and adhere to treatment requirements.

• Age between 18 and 65 years (including 18 and 60), no gender limit.
• BMI between 18 and 30 kg/m2 (including 18 and 30).
• For treatment naive patients: Did not receive standard anti-HBV treatment within 6 months prior to screening (Including interferon, NAs, and other anti-HBV drugs).
• For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs.
• HBsAg positive for at least 6 months and HBsAg between 10 and 1000 IU/mL (excluding 10 and 1000).
• HBsAb and HBeAg both are negative at screening.
• For treatment naive patients: HBV DNA < 2×10\^3 IU/mL at screening.
• For NAs treated patients: HBV DNA < 100 IU/mL at screening.
• For treatment naive patients: ALT ≤ 5ULN at screening.
• For NAs treated patients: ALT ≤ 2ULN at screening.
• Liver stiffness measurement <8.0 kPa at screening.
• Pregnancy test of female of childbearing must be negative at screening, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
• Understand and sign the informed consent form voluntarily.