Hepatitis BNCT01337479
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
An observational study of Hepatitis B, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- How many people
- 1,097 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Who may be able to join
- All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Who cannot join
None listed.
About this study
Official title: Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
Read the detailed description
Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Number of groups/cohorts: 1 (All subjects were observed in the same manner).
- Conditions
- Hepatitis B
- Medical subject headings
- Hepatitis B
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 |
|---|---|---|
| Participants of specific phase III entecavir studies | Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
defined as follows:
- Hepatic cirrhosis (Diagnosis requires biopsy or imaging study)
- Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow)
- Bleeding esophageal varices
- Ascites (Present on physical exam or imaging study)
- Hepatic encephalopathy (≥ Stage 2)
- Hepatocellular carcinoma
- Spontaneous bacterial peritonitis
- Gastric varices
- Bleeding gastric varices
- Hepatorenal syndrome
Measured: data is collected every 6 months
Secondary outcomes (7)
To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group
Measured: Every 6 months
To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group
Measured: Every 6 months
To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group
Measured: Every 6 months
To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group
Measured: Every 6 months
To determine all cause mortality by the phase III treatment group
Measured: Every 6 months
To determine HBV-related mortality by the phase III treatment group
Measured: Every 6 months
To determine Non-hepatic malignancies by the phase III treatment group
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startFeb 2003
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,097 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
- NCT01337479
- Sponsor's protocol ID
- AI463-049
- Status last verified
- Apr 2011
- First submitted
- 15 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials
- ClinicalTrials.gov ID
- NCT01337479
- Acronym / sponsor ID
- AI463-049
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,097 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Apr 2011 (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 follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
Detailed description
Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Number of groups/cohorts: 1 (All subjects were observed in the same manner).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of specific phase III entecavir studies | – | –Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Key inclusion criteria (1 listed)
- All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Key exclusion criteria (0 listed)
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
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
Time frame: data is collected every 6 months
defined as follows: * Hepatic cirrhosis (Diagnosis requires biopsy or imaging study) * Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow) * Bleeding esophageal varices * Ascites (Present on physical exam or imaging study) * Hepatic encephalopathy (≥ Stage 2) * Hepatocellular carcinoma * Spontaneous bacterial peritonitis * Gastric varices * Bleeding gastric varices * Hepatorenal syndrome
7 secondary outcomes
To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group
Time frame: Every 6 months
To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group
Time frame: Every 6 months
To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group
Time frame: Every 6 months
To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group
Time frame: Every 6 months
To determine all cause mortality by the phase III treatment group
Time frame: Every 6 months
To determine HBV-related mortality by the phase III treatment group
Time frame: Every 6 months
To determine Non-hepatic malignancies by the phase III treatment group
Time frame: Every 6 months
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 19 Apr 2011.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
Related trials for Hepatitis B
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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, 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 1 inclusion and 0 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 19 Apr 2011. 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?
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups) (time frame: data is collected every 6 months). 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 19 Apr 2011.