Trials / Completed
CompletedNCT01023230
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
A Phase Ib Dose-Escalation Study to Assess the Safety and Tolerability of DV-601 in Subjects With Chronic Hepatitis B on Concurrent Treatment With a Nucleoside Analogue
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Dynavax Technologies Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DV-601 | Six injections of DV-601 administered over a period of 12 weeks. |
| DRUG | Entecavir | Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration. |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2009-12-02
- Last updated
- 2019-04-16
Locations
4 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT01023230. Inclusion in this directory is not an endorsement.