JPRN-jRCTs061200009
Recruiting
Phase 1
Phase I/II clinical trial of retreament by therapeutic vaccine containing HBsAg and HBcAg against HBV carrier - HepBVac-J1-2
Hiasa Yoichi0 sites70 target enrollmentJuly 10, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic hepatitis B
- Sponsor
- Hiasa Yoichi
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment those who previously perticipated in phase I/II clinical trial of therapeutic vaccine
- •(1\) Positive for HBsAg or HBV\-DNA with previous history of perticipation of phase I/II clinical trial of NASVAC
- •(2\) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0\-2
- •(3\) No evidence of organ dysfunction
- •Liver: Child\-Pugh Score under 9
- •Kidney: eGFR more than 30ml/min
- •Heart: No abnormality in ECG
- •Lung: SpO2 more than 90% in room air
Exclusion 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, interferons prior 90 days
- •(8\) Inappropriate to participate in this trial
Outcomes
Primary Outcomes
Not specified
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