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

NCT01023230 | Completed Phase 1

• 2 other identifiers: DV4-HBT-022009-010142-66
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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

Keywords

DV-601; hepatitis B; entecavir; therapeutic vaccine

Outcome Measures

Primary Outcomes (1)

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

  Through Day 99

Secondary Outcomes (1)

• HBV-DNA levels

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

Study Arms (1)

DV-601

EXPERIMENTAL

Drug: DV-601; Drug: Entecavir

Interventions

DV-601 DRUG

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

DV-601

Entecavir DRUG

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

Also known as: Baraclude

DV-601

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead

Study Sites (4)

Collegium Medicum Uniwersytet im. Mikołaja Kopernika

Bydgoszcz, 85-030, Poland

Location

Samodzielny Publiczny Wojewódzki Szpital Zespolony

Szczecin, 71-455, Poland

Location

Wojewódzki Szpital Zakaźny

Warsaw, 01-201, Poland

Location

NZOZ Centrum Badan Klinicznych

Wroclaw, 50-349, Poland

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

PL (4)