A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Dynavax Technologies Corporation.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Dynavax Technologies Corporation
Information provided by:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01023230
First received: November 30, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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Purpose
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce HBV-specific virological and immunological responses in chronic hepatitis B (CHB) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: DV-601 Drug: Entecavir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Dynavax Technologies Corporation:
Primary Outcome Measures:
- Patient diaries, adverse events, physical exams, and lab tests [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- HBV-DNA levels [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DV-601 |
Drug: DV-601
Six injections of DV-601 administered over a period of 12 weeks.
Drug: Entecavir
Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
Other Name: Baraclude
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 HAV, 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023230
Contacts
| Contact: Krzysztof Majorowski, MD | +48 22 544 17 56 | kmajorowski@grs-cro.com |
Locations
| Poland | |
| Collegium Medicum Uniwersytet im. Mikołaja Kopernika | Recruiting |
| Bydgoszcz, Poland, 85-030 | |
| Samodzielny Publiczny Wojewódzki Szpital Zespolony | Recruiting |
| Szczecin, Poland, 71-455 | |
| Wojewódzki Szpital Zakaźny | Recruiting |
| Warsaw, Poland, 01-201 | |
| NZOZ Centrum Badan Klinicznych | Recruiting |
| Wrocław, Poland, 50-349 | |
Sponsors and Collaborators
Dynavax Technologies Corporation
More Information
No publications provided
| Responsible Party: | J. Tyler Martin, MD/Chief Medical Officer, Dynavax Technologies Corporation |
| ClinicalTrials.gov Identifier: | NCT01023230 History of Changes |
| Other Study ID Numbers: | DV4-HBT-02, 2009-010142-66 |
| Study First Received: | November 30, 2009 |
| Last Updated: | November 30, 2009 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Dynavax Technologies Corporation:
|
DV-601 hepatitis B entecavir therapeutic vaccine |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013