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

Launched by DYNAVAX TECHNOLOGIES CORPORATION · Nov 30, 2009

Keywords

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Gender

ALL

Eligibility 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.