Hepatitis B, ChronicNCT01155427
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)
An observational study of Hepatitis B, Chronic, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Apr 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical trial enrollees
Who may be able to join
- Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
- Age 16 years or older
- No post-transplant patients
- RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
- At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
- Study arms must include at least 10 patients
- Follow-up of at least 48 weeks
- Published results available in English language
Who cannot join
- N/A
About this study
Official title: A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.
Read the detailed description
Systematic review of prospective clinical trials
- Conditions
- Hepatitis B, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| entecavir | Patients initiating special antiviral treatments for CHB | |
| tenofovir | Patients initiating special antiviral treatments for CHB | |
| lamivudine | Patients initiating special antiviral treatments for CHB | |
| telbivudine | Patients initiating special antiviral treatments for CHB | |
| adefovir | Patients initiating special antiviral treatments for CHB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Histological improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionApr 2010
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.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 100 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
- NCT01155427
- Sponsor's protocol ID
- AI463-186
- Status last verified
- Jun 2010
- First submitted
- 29 Jun 2010
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)
- ClinicalTrials.gov ID
- NCT01155427
- Acronym / sponsor ID
- AI463-186
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Jul 2010 (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 support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.
Detailed description
Systematic review of prospective clinical trials
Study design
- Observational model
- Cohort
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| entecavir | – | –Patients initiating special antiviral treatments for CHB |
| tenofovir | – | –Patients initiating special antiviral treatments for CHB |
| lamivudine | – | –Patients initiating special antiviral treatments for CHB |
| telbivudine | – | –Patients initiating special antiviral treatments for CHB |
| adefovir | – | –Patients initiating special antiviral treatments for CHB |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical trial enrollees
Key inclusion criteria (8 listed)
- Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
- Age 16 years or older
- No post-transplant patients
- RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
- At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral load
Histological improvement
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 1 Jul 2010.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
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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?
An observational study of Hepatitis B, Chronic, 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 8 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 1 Jul 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.
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?
Viral load. The study lists 2 primary outcomes in all. 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 1 Jul 2010.