A Study to Assess DV-601 in Subjects With Chronic Hepatitis B

Dynavax Technologies Corporation

Status and phase

Completed

Phase 1

Conditions

Hepatitis B, Chronic

Treatments

Drug: Entecavir

Drug: DV-601

Study type

Interventional

Funder types

Industry

Identifiers

NCT01023230

2009-010142-66 (Registry Identifier)

DV4-HBT-02

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.