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
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: DV-601
Drug: Entecavir
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Patient diaries, adverse events, physical exams, and lab tests [ Time Frame: Through Day 99 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBV-DNA levels [ Time Frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DV-601 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023230

Locations
Poland
Collegium Medicum Uniwersytet im. Mikołaja Kopernika
Bydgoszcz, Poland, 85-030
Samodzielny Publiczny Wojewódzki Szpital Zespolony
Szczecin, Poland, 71-455
Wojewódzki Szpital Zakaźny
Warsaw, Poland, 01-201
NZOZ Centrum Badan Klinicznych
Wrocław, Poland, 50-349
Sponsors and Collaborators
Dynavax Technologies Corporation
  More Information

No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT01023230     History of Changes
Other Study ID Numbers: DV4-HBT-02, 2009-010142-66
Study First Received: November 30, 2009
Last Updated: June 16, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Dynavax Technologies Corporation:
DV-601
hepatitis B
entecavir
therapeutic vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014