Trials / Completed
CompletedNCT04289987
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine
A Randomized, Double-blinded, Placebo-controlled, Parallel, Multicenter, Phase 2b Study to Evaluate the Efficacy and Safety of CVI-HBV-002 in Patients With Chronic Hepatitis B Taking Tenofovir
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- CHA Vaccine Institute Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.
Detailed description
A randomized, double-blinded, placebo-controlled, parallel, multicenter, phase 2b study to evaluate the efficacy and safety of CVI-HBV-002 in patients with chronic hepatitis B taking Tenofovir disoproxil fumarate/Tenofovir disoproxil
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVI-HBV-002 | Investigational Product |
| BIOLOGICAL | Normal Saline(placebo) | Investigational Product |
Timeline
- Start date
- 2020-02-19
- Primary completion
- 2023-12-04
- Completion
- 2023-12-04
- First posted
- 2020-02-28
- Last updated
- 2024-02-13
Locations
9 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04289987. Inclusion in this directory is not an endorsement.