Hepatitis B VirusPhase 1NCT03083821

A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

A Phase 1 study testing Baraclude in people with Hepatitis B Virus, run by Bristol-Myers Squibb at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis B Virus
What is being tested?: Baraclude
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteJapan
Study dates: 16 May 2017to 19 Dec 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.
Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

Who cannot join

Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
Any gastrointestinal surgery that could impact upon the absorption of study drug.
Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
Other protocol defined inclusion/exclusion criteria could apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Local Institution
Hachioji-shi, Tokyo, 1920071

Other trials in Japan

About this study

Official title: A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.

Conditions: Hepatitis B Virus
Being tested: Baraclude
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BaracludeDrug
Specified dose on specified day

Study groups in NCT03083821
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Baraclude

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the peak plasma concentration
Measured: Up to 24 hours
Time of Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as the time of maximum observed plasma concentration, measured in hours
Measured: Up to 24 hours
Trough Observed Plasma (Predose) Concentration (Ctrough)
Ctrough is defined as the trough in observed plasma (predose) concentrations
Measured: prior to administration of drug (predose)
Observed Plasma Concentration at 24 Hours Postdose (C24)
C24 is defined as the observed plasma concentration at 24 hours post-dose
Measured: 24 hours post-dose
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval
Measured: Up to 24 hours
Apparent Total Body Clearance (CLT/F)
CLT/F is defined as the apparent total body clearance
Measured: Up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 201719 Dec 2017

First posted20 Mar 2017
Study start16 May 2017
Primary completion19 Dec 2017
Study completion19 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis B VirusStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03083821
Sponsor's protocol ID: AI463-528
Status last verified: Feb 2023
First submitted: 14 Mar 2017
Last updated: 18 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Hepatitis B Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Steady State Pharmacokinetics of Baraclude in Participants With Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT03083821
Acronym / sponsor ID: AI463-528
Conditions: Hepatitis B Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 16 May 2017 (actual)
Primary completion: 19 Dec 2017 (actual)
Study completion: 19 Dec 2017 (actual)
First posted: 20 Mar 2017 (actual)
Results: Posted 18 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm A	Experimental	Drug: Baraclude

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Participants with chronic hepatitis B (CHB) (excluding participants with a superinfection) who have been confirmed to have CHB.
Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10 consecutive days prior to the study enrollment.
Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

Key exclusion criteria (4 listed)

Current or recent (within 3 months of Baraclude administration) gastrointestinal disease that could impact upon the absorption of study drug.
Any gastrointestinal surgery that could impact upon the absorption of study drug.
Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
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
BaracludeSpecified dose on specified day	Drug	Arm A

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 24 hours
Cmax is defined as the peak plasma concentration
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 24 hours
Tmax is defined as the time of maximum observed plasma concentration, measured in hours
Trough Observed Plasma (Predose) Concentration (Ctrough)
Time frame: prior to administration of drug (predose)
Ctrough is defined as the trough in observed plasma (predose) concentrations
Observed Plasma Concentration at 24 Hours Postdose (C24)
Time frame: 24 hours post-dose
C24 is defined as the observed plasma concentration at 24 hours post-dose
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)]
Time frame: Up to 24 hours
AUC(TAU) is defined as the area under the concentration-time curve in one dosing interval
Apparent Total Body Clearance (CLT/F)
Time frame: Up to 24 hours
CLT/F is defined as the apparent total body clearance

Results and safety

Results posted to the registry on 18 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baraclude	6	6

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Up to 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Baraclude n = 6
Value	8.17 (2.517)

Population analysed: All treated participants with available pharmacokinetics data

Primary outcome: Time of Maximum Observed Plasma Concentration (Tmax)

Time frame: Up to 24 hours. Mean (Standard Deviation). Unit: Hours

Measure	Baraclude n = 6
Value	0.667 (0.2582)

Population analysed: All treated participants with available pharmacokinetics data

Primary outcome: Trough Observed Plasma (Predose) Concentration (Ctrough)

Time frame: prior to administration of drug (predose). Mean (Standard Deviation). Unit: ng/mL

Measure	Baraclude n = 6
Value	0 (0)

Population analysed: All treated participants with available pharmacokinetics data

Primary outcome: Observed Plasma Concentration at 24 Hours Postdose (C24)

Time frame: 24 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Baraclude n = 6
Value	0.435 (0.0678)

Population analysed: All treated participants with available pharmacokinetics data

Adverse events

Time frame: AE information should begin at initiation of study treatment until 100 days after discontinuation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baraclude	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hepatitis B Virus

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.

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?

A Phase 1 study testing Baraclude in people with Hepatitis B Virus, run by Bristol-Myers Squibb at 1 site in Japan.

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 4 inclusion and 4 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 18 Nov 2023. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) (time frame: Up to 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083821.

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 18 Nov 2023.