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

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023230
• Other study ID #: DV4-HBT-02
• Secondary ID: 2009-010142-66
• Status: Completed
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• DV-601
Six injections of DV-601 administered over a period of 12 weeks.
• Entecavir
Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.

Locations

Country	Name	City	State
Poland	Collegium Medicum Uniwersytet im. Mikolaja Kopernika	Bydgoszcz
Poland	Samodzielny Publiczny Wojewódzki Szpital Zespolony	Szczecin
Poland	Wojewódzki Szpital Zakazny	Warsaw
Poland	NZOZ Centrum Badan Klinicznych	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient diaries, adverse events, physical exams, and lab tests		Through Day 99
Secondary	HBV-DNA levels		Change from baseline to Days 43 and 99, and to Weeks 24 and 48