CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Baracludedrug
Likely dose
Baraclude (entecavir) 0.5 mg dailyAI-extracted
Key inclusion· 3
  • ✓Confirmed chronic hepatitis B (CHB) infection, excluding superinfection
  • ✓Currently treated with Baraclude 0.5 mg daily for at least 10 consecutive days before enrollment
  • ✓Body mass index 18.5 to 30 kg/m²
Key exclusion· 3
  • ✕Current or recent (within 3 months) gastrointestinal disease affecting drug absorption
  • ✕Prior gastrointestinal surgery affecting drug absorption
  • ✕Blood donation within 4 weeks of study (within 2 weeks for plasma only)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03083821
NCT03083821Phase 1Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Mar 20, 2017·Updated Nov 18, 2023

In Brief

A Phase 1 clinical trial evaluating Baraclude for Hepatitis B Virus. Completed, enrolled 6 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Virus
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 20, 2017
Enrollment StartMay 16, 2017
Primary CompletionDec 19, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.3 years ago

Interventions

Baracludedrug

Specified dose on specified day