Hepatitis B, ChronicPhase 1NCT01023230
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
A Phase 1 study testing DV-601 and Entecavir in people with Hepatitis B, Chronic, run by Dynavax Technologies Corporation at 4 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- DV-601 and Entecavir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesPoland
- Study dates
- Sep 2009to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Collegium Medicum Uniwersytet im. Mikołaja Kopernika
Bydgoszcz, 85-030
Samodzielny Publiczny Wojewódzki Szpital Zespolony
Szczecin, 71-455
Wojewódzki Szpital Zakaźny
Warsaw, 01-201
NZOZ Centrum Badan Klinicznych
Wroclaw, 50-349
About this study
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
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
- Being tested
- DV-601, Entecavir
- Keywords
- DV-601, hepatitis B, entecavir, therapeutic vaccine
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV-601Drug
Six injections of DV-601 administered over a period of 12 weeks.
EntecavirDrug
Also called Baraclude
Daily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration.
| Study group | Role | What they receive |
|---|---|---|
| DV-601 | Experimental | Not described Receives: Drug: DV-601; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient diaries, adverse events, physical exams, and lab tests
Measured: Through Day 99
Secondary outcomes (1)
HBV-DNA levels
Measured: Change from baseline to Days 43 and 99, and to Weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023230
- Sponsor's protocol ID
- DV4-HBT-02
- Other IDs
- 2009-010142-66, 2009
- Status last verified
- Apr 2019
- First submitted
- 30 Nov 2009
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: a/o August 2016, decision is still pending.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01023230
- Acronym / sponsor ID
- DV4-HBT-02
- Conditions
- Hepatitis B, Chronic
- Keywords
- DV-601, hepatitis B, entecavir, therapeutic vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DV-601 | Experimental | Drug: DV-601, Drug: Entecavir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DV-601Six injections of DV-601 administered over a period of 12 weeks. | Drug | DV-601 |
| EntecavirAlso: BaracludeDaily dosing starting approximately 4 weeks prior to first dose of DV-601 for one year total duration. | Drug | DV-601 |
Primary outcome
Patient diaries, adverse events, physical exams, and lab tests
Time frame: Through Day 99
1 secondary outcome
HBV-DNA levels
Time frame: Change from baseline to Days 43 and 99, and to Weeks 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided. a/o August 2016, decision is still pending.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DV-601 and Entecavir in people with Hepatitis B, Chronic, run by Dynavax Technologies Corporation at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient diaries, adverse events, physical exams, and lab tests (time frame: Through Day 99). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.