At a glance
ClinicalIndex Comparison RecordN/ACompleted· 246 enrolled
Drug / intervention
Methacetin Breath Testdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study of the BreathID® LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis
In Brief
A clinical study evaluating Methacetin Breath Test for Patients With Compensated Liver Cirrhosis. Completed, enrolled 246 participants across 8 sites in 4 countries.
Detailed Summary
This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg,
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Spain, Switzerland, United States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartNov 2014
Primary CompletionDec 2018
Study CompletionJan 2019
TodayJul 2026
First PostedMay 21, 2014
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2018
Study CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.1 years ago
Interventions
Methacetin Breath Testdevice
13C labelled methacetin solution for breath test monitoring