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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2017-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of BAF312 in Patients With Hepatic Impairment

NCT01565902

Hepatic Impairment

COMPLETED PHASE1

Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function

NCT04116476

Mild and Moderate Hepatic Impairment

COMPLETED PHASE1

Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function

NCT01563562

Hepatic Impairment Healthy

COMPLETED PHASE1

Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls

NCT07018492

Hepatic Impairment

RECRUITING PHASE1

Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment

NCT00859053

Hepatic Insufficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Group Type EXPERIMENTAL

Baraclude

Intervention Type DRUG

Specified dose on specified day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baraclude

Specified dose on specified day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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)

Exclusion Criteria

* 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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No