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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Dynavax Technologies Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01023230
First received: November 30, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBV-DNA levels [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: October 2010 (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 HAV, 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023230

Contacts
Contact: Krzysztof Majorowski, MD +48 22 544 17 56 kmajorowski@grs-cro.com

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

No publications provided

Responsible Party: J. Tyler Martin, MD/Chief Medical Officer, 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: November 30, 2009
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
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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 April 16, 2014