chronic hepatitis B
Conditions
Interventions
Add on pegylated-interferon alpha-2a (180 micro-g/dose) for 48 weeks in patients with chronic hepatitis B who are continuously treated with tenofovir.
Follow-up chronic hepatitis B patients without in
Sponsors
Shinshu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic hepatitis B who are treated with tenofovir for at least 12 weeks before starting pegylated-interferon add on therapy. 2) HBV DNA in serum is negative or only signal positive at starting pegylated-interferon add on therapy. 3) Amount of HBs antigen in serum is equal to or higher than 800 IU/ml. 4) Patients whose written informed consent can be obtained as a result of full explanation of the present study.
Exclusion criteria
Exclusion criteria: 1) Patients who have liver cirrhosis or hepatic failure. 2) Patients who have a complication of hepatocellular carcinoma or those who have a past history of it. 3) Patients with liver diseases which may affect clinical course of hepatitis B such as auoimmune hepatitis and alcoholic liver diseases. 4) Patients who have severe dysfunctions of organs other than the liver such as renal dysfunction and heart failure. 5) Patients who have a contraindication for pegylated interferon alha-2a in those who are assigned to pegylated-interferon add on therapy group. 6) Patients who are judged to be not eligible for the present study by corresponding physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decline of HBs antigen amount at completing pegylated interferon alpha 2a administration, and at 24 and 48 weeks after completing it | — |
Secondary
| Measure | Time frame |
|---|---|
| Factors which may be associated with rapid decline of HBs antigen amount such as clinical backgrounds, amounts of cytokines, and genetic backgrounds. | — |
Countries
Japan
Contacts
Public ContactEiji Tanaka
Shinshu University School of Medicine
Outcome results
None listed