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

April 11, 2019 updated by: Dynavax Technologies Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-030
        • Collegium Medicum Uniwersytet im. Mikołaja Kopernika
      • Szczecin, Poland, 71-455
        • Samodzielny Publiczny Wojewodzki Szpital Zespolony
      • Warsaw, Poland, 01-201
        • Wojewodzki Szpital Zakazny
      • Wrocław, Poland, 50-349
        • NZOZ Centrum Badan Klinicznych

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient diaries, adverse events, physical exams, and lab tests
Time Frame: Through Day 99
Through Day 99

Secondary Outcome Measures

Outcome Measure
Time Frame
HBV-DNA levels
Time Frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48
Change from baseline to Days 43 and 99, and to Weeks 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynavax Technologies Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DV4-HBT-02
  • 2009-010142-66 (REGISTRY: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

a/o August 2016, decision is still pending.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe