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Completed

NCT Number: NCT01023230

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collegium Medicum Uniwersytet im. Mikołaja Kopernika, Bydgoszcz, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DV-601

Drug

Six injections of DV-601 administered over a period of 12 weeks.

Entecavir

Drug

Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.

Other names: Baraclude

Primary outcomes

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

    Time frame: Through Day 99

Secondary outcomes

  1. HBV-DNA levels

    Time frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2009
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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