Clinical trial retreatment by therapeutic vaccine against HBV

Phase 1

Recruiting

• Conditions: Chronic hepatitis B; D019694

• Registration Number: JPRN-jRCTs061200009
• Lead Sponsor: Hiasa Yoichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified