Chronic Hepatitis BPhase 3NCT00036608
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
A Phase 3 study testing Entecavir in people with Chronic Hepatitis B, run by Bristol-Myers Squibb at 39 sites in United States.
Trial summary
The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Entecavir
- How many people
- Not given
- Where
- 39 sitesUnited States
- Study dates
- Jan 2002to Feb 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of HBeAg-positive chronic hepatitis B infection;
- Incomplete response to current lamivudine therapy;
- HBeAg-positive;
- Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV);
- Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Local Investigator
Ann Arbor, Michigan, 48109
Local Investigator
Atlanta, Georgia, 30309
Local Investigator
Atlanta, Georgia, 30322
Local Investigator
Birmingham, Alabama, 35294
Local Investigator
Boston, Massachusetts, 02111
Local Investigator
Charlotte, North Carolina, 28203
Local Investigator
Chicago, Illinois, 60612
Local Investigator
Chicago, Illinois, 60622
Local Investigator
Cleveland, Ohio, 44125
Local investigator
Dallas, Texas, 75235
Local Investigator
Dundalk, Maryland, 21205
Local Investigator
Durham, North Carolina, 27710
Local Investigator
Fairfax, Virginia, 22031
Local Investigator
Farmington, Connecticut, 06030
Local Investigator
Honolulu, Hawaii, 96820
Local Investigator
Iowa City, Iowa, 52242
Local Investigator
La Jolla, California, 92037
Local Investigator
Los Angeles, California, 90048
Local Investigator
Los Angeles, California, 90095
Local Investigator
Manhasset, New York, 11030
Local Investigator
Miami, Florida, 33136
Local Investigator
Miami Beach, Florida, 33140
Local Investigator
Nashville, Tennessee, 37211
Local Investigator
New Orleans, Louisiana, 70112
Local Investigator
New York, New York, 10003
Local Investigator
New York, New York, 10029
Local Investigator
New York, New York, 10032
Local Investigator
Orange, California, 92868
Local Investigator
Philadelphia, Pennsylvania, 19104
Local Investigator
Pittsburgh, Pennsylvania, 15213
Local Investigator
Providence, Rhode Island, 02908
Local Investigator
Richmond, Virginia, 23249
Local Investigator
Rochester, New York, 14642
Local Investigator
Royal Oak, Michigan, 48073
Local Investigator
Saint Paul, Minnesota, 55114
Local Investigator
San Diego, California, 92115
Local Investigator
San Francisco, California, 94115
Local Investigator
Tucson, Arizona, 85724
Local Investigator
Worcester, Massachusetts, 01655
About this study
The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
- Conditions
- Chronic Hepatitis B
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
- Study startJan 2002
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036608
- Sponsor's protocol ID
- AI463-026
- Status last verified
- Jan 2010
- First submitted
- 10 May 2002
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine
- ClinicalTrials.gov ID
- NCT00036608
- Acronym / sponsor ID
- AI463-026
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 13 May 2002 (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 clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Entecavir | Drug | – |
Primary outcome
Not reported in the source record.
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 14 Apr 2011.
Related trials for Chronic Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir in people with Chronic Hepatitis B, run by Bristol-Myers Squibb at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. 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 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.
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 14 Apr 2011.