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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
DV-601
Entecavir
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring DV-601, hepatitis B, entecavir, therapeutic vaccine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Collegium Medicum Uniwersytet im. Mikołaja Kopernika
  • Samodzielny Publiczny Wojewódzki Szpital Zespolony
  • Wojewódzki Szpital Zakaźny
  • NZOZ Centrum Badan Klinicznych

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DV-601

Arm Description

Outcomes

Primary Outcome Measures

Patient diaries, adverse events, physical exams, and lab tests

Secondary Outcome Measures

HBV-DNA levels

Full Information

First Posted
November 30, 2009
Last Updated
April 11, 2019
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01023230
Brief Title
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
DV-601, hepatitis B, entecavir, therapeutic vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DV-601
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DV-601
Intervention Description
Six injections of DV-601 administered over a period of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
Primary Outcome Measure Information:
Title
Patient diaries, adverse events, physical exams, and lab tests
Time Frame
Through Day 99
Secondary Outcome Measure Information:
Title
HBV-DNA levels
Time Frame
Change from baseline to Days 43 and 99, and to Weeks 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Collegium Medicum Uniwersytet im. Mikołaja Kopernika
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Samodzielny Publiczny Wojewódzki Szpital Zespolony
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Wojewódzki Szpital Zakaźny
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
NZOZ Centrum Badan Klinicznych
City
Wrocław
ZIP/Postal Code
50-349
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
a/o August 2016, decision is still pending.

Learn more about this trial

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

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