13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 10, 2016

Primary Completion Date

September 18, 2019

Study Completion Date

September 18, 2019

Conditions
Acute Liver Failure
Interventions
DRUG

13C-Methacetin

"The test substrate in this study, ¹³C-methacetin solution for single-use oral administration (75 mg in 150 ml purified water), is administered orally or via feeding tube, rapidly absorbed, exclusively metabolized by hepatic mixed function oxidase via O-demethylation, mainly by cytochrome P450 enzyme, subtype 1A2, into acetaminophen and formaldehyde. The formaldehyde is then transformed through two successive oxidative steps to ¹³carbon dioxide, the quantity of which is measured in exhaled breath as a ratio of 13C to 12C.~The nasal or intubated breath sampling investigational device (ID) circuit continuously transports the breath sample from the patient to the BreathID® MCS device before and following administration of the 13C-methylacetanilide test substrate."

Trial Locations (11)

23298

VCU Medical Center, Richmond

29425

Medical University of South Carolina, Charleston

35294

University of Alabama, Birmingham, Birmingham

43210

Ohio State University Medical Center, Columbus

48109

University of Michigan, Ann Arbor

60611

Northwestern University, Chicago

66160

University of Kansas Medical Center, Kansas City

94143

University of California, San Francisco, San Francisco

98195

University of Washington Medical Center, Seattle

06520

Yale University School of Medicine, New Haven

75390-8887

UT Southwestern Medical Center at Dallas, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical University of South Carolina

OTHER

collaborator

University of Michigan

OTHER

collaborator

Meridian Bioscience, Inc.

INDUSTRY

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Texas Southwestern Medical Center

OTHER

NCT02786836 - 13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF | Biotech Hunter | Biotech Hunter