CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
Suspected NASH BreathID test with 13C-Octanoate +1 moredevice
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.

Search/NCT02314026
NCT02314026Phase 2Completed

Clinical Study of the BreathID® System to Train the Algorithm for the ¹³C-Octanoate Breath Test With or Without the ¹³C-Methacetin Breath Test (OBT and MBT Respectively) for Correlation With Histological Findings Associated With Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases

Meridian Bioscience, Inc.·interventional·Posted Dec 10, 2014·Updated Dec 20, 2022

In Brief

A Phase 2 clinical trial evaluating Suspected NASH BreathID test with 13C-Octanoate and Suspected NASH Breath test with 13C Methacetin for Non-Alcoholic Steatohepatitis. Completed, enrolled 140 participants across 11 sites in 4 countries.

Detailed Summary

This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases using the BreathID® System

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 10, 2014
Enrollment StartMar 1, 2015
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.6 years ago

Interventions

Suspected NASH BreathID test with 13C-Octanoatedevice

Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetindevice

Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water