JRCT ID: jRCTs061180100
Registered date:25/03/2019
Clinical trial for therapeutic vaccine against HBV
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | chronic hepatitis B |
Date of first enrollment | 05/01/2017 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | NASVAC (HBsAg 80 microgram, HBcAg 80 microgram) given every 2 weeks for 10 times via nasal route to HBV carrier (HBV asymptomatic carrier and CHB patient treating with NUCs) |
Outcome(s)
Primary Outcome | HBsAg reduction |
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Secondary Outcome | Anti-HBs induction, HBV-DNA reduction, HBeAg seroconversion |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 85age old |
Gender | Both |
Include criteria | HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment after obtaining written informed consent (1) Positive for HBsAg or HBV-DNA (2) Eastern Cooperative Oncology Group (EOCG) Perforrmance Status (PS) 0-2 (3) No evidence of organ dysfunction Liver: Child Pugh Score <9 Kidney: eGFR >30 ml/min Heart: No abnormality in ECG Lung: Sp2 >92% |
Exclude criteria | (1) Allergic history against 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 and interferons (8) Inappropriate to participate in this trial |
Related Information
Primary Sponsor | Hiasa Yoichi |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Osamu Yoshihda |
Address | 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295 |
Telephone | +81-89-960-5308 |
yoshidao@m.ehime-u.ac.jp | |
Affiliation | Ehime University |
Scientific contact | |
Name | Yoichi Hiasa |
Address | 454 Shitsukawa, Toon, Ehime Ehime Japan 791-0295 |
Telephone | +81-89-960-5308 |
hiasa@m.ehime-u.ac.jp | |
Affiliation | Ehime University |