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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01023230
First received: November 30, 2009
Last updated: June 16, 2014
Last verified: June 2014

November 30, 2009
June 16, 2014
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 ] [ Designated as safety issue: Yes ]
Patient diaries, adverse events, physical exams, and lab tests [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01023230 on ClinicalTrials.gov Archive Site
HBV-DNA levels [ Time Frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48 ] [ Designated as safety issue: No ]
HBV-DNA levels [ Designated as safety issue: No ]
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
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Drug: DV-601
  • Drug: Entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01023230
DV4-HBT-02, 2009-010142-66
No
Dynavax Technologies Corporation
Dynavax Technologies Corporation
Not Provided
Not Provided
Dynavax Technologies Corporation
June 2014

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