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

NCT ID: NCT01023230

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DV-601

Group Type: EXPERIMENTAL

DV-601

Intervention Type: DRUG

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

Entecavir

Intervention Type: DRUG

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

Interventions

DV-601

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

Intervention Type: DRUG

Entecavir

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

Intervention Type: DRUG

Other Intervention Names

Baraclude

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dynavax Technologies Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Collegium Medicum Uniwersytet im. Mikołaja Kopernika

Bydgoszcz, , Poland

Samodzielny Publiczny Wojewódzki Szpital Zespolony

Szczecin, , Poland

Wojewódzki Szpital Zakaźny

Warsaw, , Poland

NZOZ Centrum Badan Klinicznych

Wroclaw, , Poland

Countries

Poland

Other Identifiers

2009-010142-66

Identifier Type: REGISTRY

Identifier Source: secondary_id

DV4-HBT-02

Identifier Type: -

Identifier Source: org_study_id