A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
- Registration Number
- NCT01023230
- Lead Sponsor
- Dynavax Technologies Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DV-601 DV-601 - DV-601 Entecavir -
- Primary Outcome Measures
Name Time Method Patient diaries, adverse events, physical exams, and lab tests Through Day 99
- Secondary Outcome Measures
Name Time Method HBV-DNA levels Change from baseline to Days 43 and 99, and to Weeks 24 and 48
Trial Locations
- Locations (4)
Collegium Medicum Uniwersytet im. Mikołaja Kopernika
🇵🇱Bydgoszcz, Poland
NZOZ Centrum Badan Klinicznych
🇵🇱Wrocław, Poland
Wojewódzki Szpital Zakaźny
🇵🇱Warsaw, Poland
Samodzielny Publiczny Wojewódzki Szpital Zespolony
🇵🇱Szczecin, Poland