drugset / Trial / NCT04289987

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine

NCT04289987 ↗

Phase 2 Completed 134 enrolled CHA Vaccine Institute Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.

Timeline

Start
2020-02-19
Primary completion
2023-12-04
Completion
2023-12-04

Outcome

Missed primary endpoint

release “1차 유효성 평가변수인 ‘혈청 내 HBsAg(B형 간염 표면항원)’ 수치의 평균 변화를 분석한 결과, CVI-HBV-002 투여군에서 HBsAg 수치 감소가 관찰되었으나, 위약군과 비교해 통계적으로 유의한 차이는 확인되지 않았다(p값=0.4811).” chabio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CVI-HBV-002 Vaccine 20 ug Intramuscular