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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: DV-601
* Drug: Entecavir


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DV-601<br> | Drug: DV-601<br>* Six injections of DV-601 administered over a period of 12 weeks.<br>Drug: Entecavir<br>* Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.<br>* Other names: Baraclude;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DV-601, hepatitis B, entecavir, therapeutic vaccine