Examination of efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B

Not Applicable

Recruiting

• Conditions: chronic hepatitis B

• Registration Number: JPRN-UMIN000006659
• Lead Sponsor: Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient who is administering the sho-sai-ko-to 2. A patient with the previous history of interstitial pneumonia 3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha-2a or other IFNs 5. Patient who has previous history of hypersensitivity for biological products such as vaccines 6. Patient with cirrhosis, liver failure, and liver carcinoma 7. Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history 8. A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses 9. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history 11. The patient of uncontrollable hypertension 12. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack) 13. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 14. Additionally, patient judged by doctor that participation in this study is improper 15. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[HBeAg-positive chronic hepatitis B] Efficacy assessed after 24 weeks of follow up for HBeAg seroconversion [HBeAg-negative chronic hepatitis B] This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for 1)the suppression of HBV DNA levels to below 4.3Log copies/ml 2)the normalization of alanine aminotransferase levels (below 40IU/L)