Hepatitis B
Conditions
Interventions
Case series:nucleos(t)ide analogue combined with Peginterferon a-2b
Sponsors
Second People's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years; 2. Confirmed chronic hepatitis B patientsdefined as serum HBsAg positive at least 6 months; 3. Being treated with NUCS (lamivudine, adefovir, entecavir and tenofovir, except for telbivudine) before the start of the study; 4. Child-Pugh score <7; 5. Without contraindications to interferon; 6. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the one week period prior to the first dose of test drug. All patients with effective birth control measures during treatment period and 6 months after the treatment. 7. Agree to participate in the study and sign the patient informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of decompensated liver disease (Child-Pugh score > 7) or history of decompensated liver disease; 2. Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein > 100 ng/mL are excluded. If alpha-fetoprotein is between 2 ULN and 100 ng/mL, recheck is needed after 2 weeks, alpha-fetoprotein still > 100 ng/mL are excluded, or alpha-fetoprotein cannot maintain stable and/or liver imaging prompt liver tumor within 3 months before the test are excluded; 3. Co-infection with active hepatitis A, hepatitis C, hepatitis D or human immunodeficiency virus (HIV) or combination of any other liver diease; 4. Contraindication with interferon such as pregnancy, no control of hypertension, diabetes, thyroid disease and have been diagnosed or suspected myositis, peripheral neuropathy or myopathy, severe retinopathy history or or other evidence of retinopathy, history of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as severe depression or psychosis, suicide attempt, hospitalization for psychosis, or a period of disability due to a psychiatric disease; 5. Alcohol consumed over 40g/day or abuse of prohibited drugs within one year; 6. Need to use systemic acyclovir or famciclovir frequently; need to use systemic corticosteroids frequently (local or inhaled use are allowed); 7. Use the Hepatotoxic drugs (including but not limited to dapsone, fluconazole, ketoconazole, erythromycin, rifampicin and other anti-tuberculosis drugs) or nephrotoxic drugs (including but not limited to non-steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, foscarnet) within one month and need to continue long-term use of them; 8. Fibroscan>14 or B-ultrasound /CT imaging prompt moderate liver cirrhosis or evidence of decompensated liver disease (Child-Pugh score =7); 9. Diseases caused by chronic liver disease or other evidence of diseases caused by chronic liver disease (such as hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, etc.); 10. Neutrophil count 1.5 ULN; 11. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.) or abnormal increase of autoimmunity antibody level; 12. Combined with serious other organ diseases (heart, brain, kidney, etc.); 13. Women with ongoing pregnancy or breast-feeding or patients have pregnancy plan and not willing to have contraception; 14. Allergic to interferon and its components or polyethylene glycol; 15. History of any organ system tumor in the past 5 years; 16. Poor compliance or any situations interfering the studyOther situations that researchers believe it is not appropriate for inclusion; 17. History of serious diseases or evidence of serious diseases or other diseases that researchers believe it is not appropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg loss rate at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg decline level from baseline;HBsAg seroconversion;HBeAg seroconversion;Cumulative incidence of hepatocellular carcinoma;Cumulative incidence of liver fibrosis, cirrhosis and liver failure;Adverse events, vital signs and clinical laboratory indicators; | — |
Countries
China
Contacts
Public ContactWEI JIA
Second People's Hospital of Yunnan Province
Outcome results
None listed