A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.
Phase 4
Completed
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000021768
- Lead Sponsor
- Department of Gastroenterology,Saitama Medical Center, Jichi Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
(1)The patients who are prescribed with Sho-saiko-toh. (2)The patients who had or have interstitial pneumonia. (3)The patients with autoimmune hepatitis. (4)The patients who have an allergy against interferon and other medications in the study. (5)The patients who have allergy against vaccine or other biologics. (6)The patients with a severe mental disease such as depression, a suicide consideration, or suicide project, or the past history of such conditions. (7)The patients with liver cirrhosis or severe hepatic diseases. (8)The patients with untreated hepatic cancers. (9)The patients who were judged inappropriate for the study by the doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of patients who achieve > 0.5 logU/ml reduction of HBsAg after 24 and 48 weeks.
- Secondary Outcome Measures
Name Time Method (1)Change of ALT (2)Change of HBeAg (3)HBV-specific immunological reactions