Hepatitis B, ChronicNCT01356901
Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients
An observational study of Hepatitis B, Chronic, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CHB Patients treated by Gastroenterologists/Hepatologists
Who may be able to join
- Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
- Written informed consent
Who cannot join
- All relevant conditions according to Summary of product characteristics (SmPC)
- Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
- Patients currently included in any investigational trial on CHB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life
The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.
Read the detailed description
Sampling Method: Probability Sample (consecutive patient sampling)
- 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 |
|---|---|---|
| Treatment naïve and pre-treated CHB patients | subanalysis with migrant and non-migrant patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit.
Measured: After 2 years
Secondary outcomes (7)
Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)
Measured: After 2 years
Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)
Measured: After 2 years
Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss
Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT)
Measured: After 2 years
Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs
Measured: After 2 years
Number of participants with occuring resistances based on results from resistance tests
Measured: After 2 years
Assessment of Health Status (SF-12® Health Survey)
Measured: Assessment of Health Status (SF-12 Health Survey) at year 1
Assessment of Health Status (SF-12® Health Survey)
Measured: Assessment of Health Status (SF-12 Health Survey) at year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
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
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356901
- Sponsor's protocol ID
- AI463-232
- Status last verified
- Jun 2015
- First submitted
- 15 Apr 2011
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life
- ClinicalTrials.gov ID
- NCT01356901
- Acronym / sponsor ID
- AI463-232
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 May 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 observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.
Detailed description
Sampling Method: Probability Sample (consecutive patient sampling)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment naïve and pre-treated CHB patients | – | –subanalysis with migrant and non-migrant patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHB Patients treated by Gastroenterologists/Hepatologists
Key inclusion criteria (2 listed)
- Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
- Written informed consent
Key exclusion criteria (3 listed)
- All relevant conditions according to Summary of product characteristics (SmPC)
- Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
- Patients currently included in any investigational trial on CHB
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
Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
Time frame: After 2 years
A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit.
7 secondary outcomes
Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)
Time frame: After 2 years
Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)
Time frame: After 2 years
Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss
Time frame: After 2 years
Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs
Time frame: After 2 years
Number of participants with occuring resistances based on results from resistance tests
Time frame: After 2 years
Assessment of Health Status (SF-12® Health Survey)
Time frame: Assessment of Health Status (SF-12 Health Survey) at year 1
Assessment of Health Status (SF-12® Health Survey)
Time frame: Assessment of Health Status (SF-12 Health Survey) at year 2
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 7 Jul 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Bristol-Myers Squibb at 1 site in Germany.
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 2 inclusion and 3 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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting. (time frame: After 2 years). 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 7 Jul 2015.