Chronic hepatitis B
Conditions
Interventions
Peg-interferon alpha-2a (Pegasys) 180 microg/week subcutaneously for 48 weeks
Sponsors
Department of general internal medicine, Kyushu-University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 years old and over. 2. Patients with chronic hepatitis B. 3. Patients who meet the following conditions before the start of therapy. A. Neutrophil counts; 1,500 microliter and over. B. Platelet counts; 90,000 microliter and over. C. Hemoglobin concentrations; 10 g/dL and over. 4. Patients who is explained well about this study and is obtained signed informed consent form to this study with free will.
Exclusion criteria
Exclusion criteria: Patients with the following are excluded: 1. Patients who are taking herbal medicine, syo-saiko-to. 2. Previous history of interstitial pneumonia. 3. Other chronic liver diseases such as autoimmune hepatitis, alcoholic liver disease. 4. Previous history of hypersensitivity to peginterferon-alpha-2a or other interferon products. 5. Previous history of hypersensitivity to biologicals such as vaccines. 6. Liver cirrhosis, liver failure and hepatocellular carcinoma. 7. Patients who have hepatic encephalaopathy, esophageal varices, ascites, or those previous history. 8. Patients who have autoimmune diseases such as hemolytic anemia, ulcerative colitis, rheumatoid arthritis, or those previous history. 9. Patients who have heart diseases difficult to control. 10. Patients who have depression, epileptic seizure, or mental disorders with continuous treatment, or those previous history. 11. Uncontrollable hypertension. 12. Previous history of cerebrovascular diseases such as brain infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack. 13. Diabetes mellitus receiving medical treatment. 14. Patients who are pregnant or lactating women. 15. Patients who are receiving nucleotide analogues treatments within three months. 16. Patients who are disquialified to participate in this trial judged by attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Efficacy> A. In patients with HBe Ag positive chronic hepatitis B at the start of therapy. At the 24 weeks after the end of therapy 1. The proportion of patients with HBe Ag seroconvertsion. 2. The proportion of patients achieving HBV DNA less than 5.0 log copies/mL. 3. The proportion of patients achieving ALT 40 U/L and fewer. B. In patients with HBe Ag negative chronic hepatitis B at the start of therapy. At the 24 weeks after the end of therapy 1. The proportion of patients achieving HBV DNA less than 4.3 log copies/mL 2. The proportion of patients achieving ALT 40 U/L and fewer. <Safety> 1. Adverse events, clinical laboratory tests (the changes in neutrophil and , platelet counts, hemoglobin levels) 2. Treatment continuation, reduction, and discountinuation rates, the reason for discontinuation of treatment. | — |
Countries
Japan
Contacts
Public ContactMasayuki Murata
Kyushu University Hospital Department of general internal medicine
Outcome results
None listed