Trials / Completed
CompletedNCT02097004
Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection
Phase4, to Compare Efficacy and Safety of Therapeutic Vaccination With Intensified Schedule Plus Pegylated Interferon Dual Therapy on Seroclearance of HBS Antigen in Patients With Complete Virological Response Induced by Entecavir
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir
Detailed description
A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir (E + VIP)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Peginterferon alfa-2a | once weekly 180 μg subcutaneous injection for 48 weeks |
| BIOLOGICAL | HBV vaccination | 1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks |
| DRUG | Entecavir | Continue Entecavir(0.5mg) for 100 weeks |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2018-01-01
- Completion
- 2018-03-13
- First posted
- 2014-03-26
- Last updated
- 2018-05-09
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02097004. Inclusion in this directory is not an endorsement.