Hepatitis B, Chronic
Conditions
Keywords
DV-601, hepatitis B, entecavir, therapeutic vaccine
Brief 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.
Interventions
DRUGDV-601
Six injections of DV-601 administered over a period of 12 weeks.
DRUGEntecavir
Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects 18 to 65 years of age. * Signed informed consent. * Diagnosis of CHB and candidates for therapy * Normal renal function * Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.
Exclusion criteria
* Liver disease other than CHB * Documented co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), or HIV * Previous therapy with interferon alpha. * Any other antiviral therapy for chronic hepatitis B within the previous 3 months prior to Screening Visit. * Immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of Screening Visit. * Evidence of cirrhosis * Child-Turcotte-Pugh (CTP) score ≥ 7, either currently or at any occasion in the past * Clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history. * Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix. * Participation in any experimental protocol or therapy within 28 days prior to the Screening Visit. * Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient diaries, adverse events, physical exams, and lab tests | Through Day 99 |
Secondary
| Measure | Time frame |
|---|---|
| HBV-DNA levels | Change from baseline to Days 43 and 99, and to Weeks 24 and 48 |
Countries
Poland
Outcome results
None listed