Chronic Hepatitis B VirusPhase 3NCT00975091
Continue Entecavir Rollover From China
A Phase 3 study testing Entecavir in people with Chronic Hepatitis B Virus, run by Bristol-Myers Squibb.
Trial summary
The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Chronic Hepatitis B Virus
- What is being tested?
- Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Aug 2007
- Phase
- Phase 3
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
- ALT ≤ 15 x upper limit of normal
- Compensated liver disease
Who cannot join
- Coinfection with HIV, HCV, or HDV
About this study
Official title: A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China
The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.
- Conditions
- Chronic Hepatitis B Virus
- Being tested
- Entecavir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Baraclude, BMS-200475
Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
EntecavirDrug
Also called Baraclude, BMS-200475
Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
| Study group | Role | What they receive |
|---|---|---|
| Entecavir 0.5 | Active comparator | Not described Receives: Drug: Entecavir |
| Entecavir 1.0 | Active comparator | Not described Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
Measured: Through 3 years of dosing and up to 48 weeks of off treatment follow up
Secondary outcomes (1)
The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort
Measured: Through 3 years of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startMay 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B VirusStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975091
- Sponsor's protocol ID
- AI463-050
- Status last verified
- Nov 2009
- First submitted
- 8 Sep 2009
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China
- ClinicalTrials.gov ID
- NCT00975091
- Acronym / sponsor ID
- AI463-050
- Conditions
- Chronic Hepatitis B Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 11 Sep 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 the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir 0.5 | Active comparator | Drug: Entecavir |
| Entecavir 1.0 | Active comparator | Drug: Entecavir |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
- ALT ≤ 15 x upper limit of normal
- Compensated liver disease
Key exclusion criteria (1 listed)
- Coinfection with HIV, HCV, or HDV
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 |
|---|---|---|
| EntecavirAlso: Baraclude, BMS-200475Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started | Drug | Entecavir 0.5 |
| EntecavirAlso: Baraclude, BMS-200475Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started | Drug | Entecavir 1.0 |
Primary outcome
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
Time frame: Through 3 years of dosing and up to 48 weeks of off treatment follow up
1 secondary outcome
The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort
Time frame: Through 3 years of dosing
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 2 Feb 2010.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir in people with Chronic Hepatitis B Virus, run by Bristol-Myers Squibb.
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 3 inclusion and 1 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events (time frame: Through 3 years of dosing and up to 48 weeks of off treatment follow up). 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 2 Feb 2010.