Analysis for the efficacy and safety of peginterferon-alpha-2a monotherapy on chronic active hepatitis B patients

Not Applicable

Completed

• Conditions: Chronic hepatitis B

• Registration Number: JPRN-UMIN000018020
• Lead Sponsor: Department of general internal medicine, Kyushu-University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<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.