Clinical trial of therapeutic vaccine against chronic hepatitis B patients under NAs treatment
- Conditions
- chronic hepatitis BD019694
- Registration Number
- JPRN-jRCTs061210086
- Lead Sponsor
- Hiasa Yoichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Chronic hepatitis B patients who fulfill the inclusion criteria below
(1) 20-85 years old
(2) Positive fo HBsAg or HBV-DNA
(3) Taking nucleos(t)ide analogue
(4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS: 0-2)
(5) No evidence of organ dysfunction
Liver: Child-Pugh Score less than 9
Kidney: eGFR more than 30
Heart: No severe heart failure by interview
Lung: SpO2 above 90% in room air
1) Allergic history of past vaccination
(2) Pregnant, unwilling to practice contraception during the study or lactating female
(3) Severe complication (malignant hypertension,severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia)
(4) Bearing malignant carcinoma including HCC
(5) Severe mental disability
(6) Positive for HCV-RNA
(7) Taking immunosuppressive drugs, steroid, interferon prior 90 days
(8) Inappropriate to participate in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method amount of HBsAg reduction<br>HBsAg loss (below 0.005 IU/mL) rate
- Secondary Outcome Measures
Name Time Method amount of HBV-DNA reduction<br>amount of HBcrAg reduction<br>HBeAg seroconversion rate<br>anti-HBs induction (more than 1.0 mIU/mL) rate<br>HBcAg specific CTL induction