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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dynavax Technologies Corporation
• Treatments: Entecavir

Criteria

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.