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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023230
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Dynavax Technologies Corporation

November 30, 2009
December 2, 2009
March 1, 2018
September 2009
May 2011   (Final data collection date for primary outcome measure)
Patient diaries, adverse events, physical exams, and lab tests [ Time Frame: Through Day 99 ]
Patient diaries, adverse events, physical exams, and lab tests
Complete list of historical versions of study NCT01023230 on Archive Site
HBV-DNA levels [ Time Frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48 ]
HBV-DNA levels
Not Provided
Not Provided
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
A Phase Ib Dose-Escalation Study to Assess the Safety and Tolerability of DV-601 in Subjects With Chronic Hepatitis B on Concurrent Treatment With a Nucleoside Analogue
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: DV-601
    Six injections of DV-601 administered over a period of 12 weeks.
  • Drug: Entecavir
    Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
    Other Name: Baraclude
Experimental: DV-601
  • Drug: DV-601
  • Drug: Entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2009-010142-66 ( Registry Identifier: EudraCT )
Not Provided
Plan to Share IPD: Undecided
Plan Description: a/o August 2016, decision is still pending.
Dynavax Technologies Corporation
Dynavax Technologies Corporation
Not Provided
Not Provided
Dynavax Technologies Corporation
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP