Phase 3 N=414 Single-blind Diagnostic

BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Chronic Liver Disease

Bottom Line

View on ClinicalTrials.gov: NCT00736840 ↗

Enrolled (actual)

414

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcome: Primary: Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS) — 146 Participants — p=0.0924

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: c13 methacetin solution with breath analyzer (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Meridian Bioscience, Inc.
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)	146	0.0924
SECONDARY AUC of ROC (Area Under Receiver Operating Characteristic Curve)	0.785	<0.0001 sig

Summary

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Eligibility Criteria

Inclusion Criteria

Age >18 with chronic liver disease

Exclusion Criteria

Patients that are taking hepatotoxin drug.
Patient with severe congestive heart failure
Patient with severe pulmonary hypertension
Patient with uncontrolled diabetes mellitus
Patient with previous surgical bypass surgery for morbid obesity
Patient with extensive small bowel resection
Patient currently receiving total parenteral nutrition
Patient is a recipients of any organ transplant
Patients that received any anti-viral treatment within the past year
Women who are pregnant
Patient allergic to acetaminophen (such as Tylenol or any other related medications)
Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
Patients unable to sign informed consent
Patients that based on the opinion of the investigator should not be enrolled into this study
Patients that are participating in other clinical trials evaluating experimental treatments or procedures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00736840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.