Hepatitis BNCT03426618
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
An observational study of Hepatitis B, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial summary
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Non-interventional
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2018to 13 Mar 2019
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.
Who may be able to join
- Signed informed consent
- 2 to < 16 years of age
- Patients with chronic hepatitis B infection, eligible for treatment with Baraclude as indicated in the locally approved prescribing information
Who cannot join
- Off-label use of the approved label in Baraclude pediatric indication
- Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.
- Conditions
- Hepatitis B
- Being tested
- Non-interventional
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Pediatric participants with Hepatitis B Virus (HBV) | All participants who received at least 1 dose of Baraclude. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Measured: Up to 52 weeks
Secondary outcomes (13)
Participants who achieved a virologic response
Measured by reduction in hepatitis B virus DNA to <300 copies/mL
Measured: Up to 48 weeks
Mean log reduction in hepititis B virus DNA
Measured: Baseline to Weeks 12, 24, and 48
Liver stiffness
Measured: Baseline and Week 48 of treatment
Number of participants with resistance to Baraclude
Measured: Up to 52 weeks
Number of participants with virologic relapse in participants
Viral load of less than or equal to 300 copies/mL
Measured: Up to 48 weeks
Number of participants with virologic Relapse in participants
Viral load greater than 10,000 copies/mL
Measured: Up to 48 weeks
Number of participants who were HBeAg seroconverted at Week 48
Measured: Week 48
Number of participants who had HBeAg loss at week 48
Measured: Week 48
Number of participants who were HBsAg seroconverted at Week 48
Measured: Week 48
Number of participants who had HBsAg loss at week 48
Measured: Week 48
Number of participants with normalization of serum ALT at week 12
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Measured: Baseline to week 12
Number of participants with normalization of serum ALT at week 24
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Measured: Baseline to week 24
Number of participants with normalization of serum ALT at week 48
Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT
Measured: Baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start12 Jan 2018
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
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 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
- NCT03426618
- Sponsor's protocol ID
- AI463-514
- Status last verified
- May 2019
- First submitted
- 2 Feb 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03426618
- Acronym / sponsor ID
- AI463-514
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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.
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric participants with Hepatitis B Virus (HBV) | – | Other: Non-interventionalAll participants who received at least 1 dose of Baraclude. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.
Key inclusion criteria (3 listed)
- Signed informed consent
- 2 to < 16 years of age
- Patients with chronic hepatitis B infection, eligible for treatment with Baraclude as indicated in the locally approved prescribing information
Key exclusion criteria (3 listed)
- Off-label use of the approved label in Baraclude pediatric indication
- Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-interventionalNon-interventional | Other | Pediatric participants with Hepatitis B Virus (HBV) |
Primary outcome
Number of Adverse Events (AEs)
Time frame: Up to 52 weeks
13 secondary outcomes
Participants who achieved a virologic response
Time frame: Up to 48 weeks
Mean log reduction in hepititis B virus DNA
Time frame: Baseline to Weeks 12, 24, and 48
Liver stiffness
Time frame: Baseline and Week 48 of treatment
Number of participants with resistance to Baraclude
Time frame: Up to 52 weeks
Number of participants with virologic relapse in participants
Time frame: Up to 48 weeks
Number of participants with virologic Relapse in participants
Time frame: Up to 48 weeks
Number of participants who were HBeAg seroconverted at Week 48
Time frame: Week 48
Number of participants who had HBeAg loss at week 48
Time frame: Week 48
Number of participants who were HBsAg seroconverted at Week 48
Time frame: Week 48
Number of participants who had HBsAg loss at week 48
Time frame: Week 48
Number of participants with normalization of serum ALT at week 12
Time frame: Baseline to week 12
Number of participants with normalization of serum ALT at week 24
Time frame: Baseline to week 24
Number of participants with normalization of serum ALT at week 48
Time frame: Baseline to week 48
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 3 Jun 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
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Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
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RecruitingObservational study
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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, run by Bristol-Myers Squibb at 1 site in South Korea.
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 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 3 Jun 2019. 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 South Korea. 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?
Number of Adverse Events (AEs) (time frame: Up to 52 weeks). 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 3 Jun 2019.