drugset / Trial / NCT04289987
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CVI-HBV-002 | Vaccine | 20 ug | Intramuscular |