Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350714
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2006-07-10
Brief Title:
BreathID Multi-center HCV Liver Breath Test Study
Sponsor:
Meridian Bioscience Inc
Organization:
Meridian Bioscience Inc
Study Overview
Official Title:
Validation of a Breath Test for Assessment of Liver Fibrosis in Patients With Chronic Hepatitis C Viral Infection
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to FDA comments protocol changed new trial will be proposed shortly
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to validate the BreathID 13C-methacetin breath test MBT as a non-invasive simple-to-use metabolic test which could be utilized to detect severe liver fibrosis 2 in METAVIR in patients with chronic HCV liver diseaseThe test is a breath-test using a free-standing device BreathID that measures metabolization of a 13C-labeled substrate 13C-methacetin in real time
Detailed Description:
Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic HCV liver disease During this procedure a core sample of liver is obtained and examined histologically for the presence of inflammation fibrosis and other features characteristic of specific liver disorders Several grading systems have been developed over the past 2 decades to quantify the overall severity of the liver biopsy specimen Although liver biopsy is the gold standard by which to assess liver disease severity the procedure has significant limitations Liver biopsy is a costly invasive procedure with risks for morbidity and mortality and may cause some discomfort to the patient Percutaneous liver biopsy is associated with potential complications including bleeding 1-3 pain 20-30 bile peritonitis 1 pneumothorax 1 punctured viscera 1 and death In addition liver biopsy and examination of liver histology is subject to sampling variation and the manner by which these findings are evaluated and reported by individual pathologists
Breath testing with 13C-labeled substrates provide a safe non-invasive means for evaluating hepatic metabolism that is correlated with liver histology 13C is a stable non-radioactive isotope which can by incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver Ideally the 13C-compound would need to be administered orally rapidly absorbed exclusively metabolized by the liver metabolism and 13C would be measured in exhaled breath within 20-30 minutes Hepatic metabolism of the compound is assessed by measuring the ratio of 13C12C in exhaled breath The ability to detect differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the BreathID collection system and analyzer unit
The compound selected for this study will be 13C-methacetin Methacetin meets all of the qualifications for an excellent substrate for liver breath tests It is a non-toxic small molecule 13C can be synthesized into a key location within this agent It can be administered orally in solution It is rapidly absorbed and metabolized by hepatic microsomes and this process releases CO2 as a by-product in exhaled breath No reports of any complications or side effects using this substance have been reported
13C-methacetin is rapidly absorbed and metabolized by healthy liver cells into acetaminophen and 13CO2 The resultant CO2 can be measured in the exhaled breath The amount of metabolized methacetin indicates the capability of the liver to accomplish one of its main physiological tasks and has been shown to correlate with liver fibrosis and cirrhosis
Breath testing with 13C-labeled substrates provide a safe non-invasive means for evaluating hepatic metabolism that is correlated with liver histology 13C is a stable non-radioactive isotope which can by incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver Ideally the 13C-compound would need to be administered orally rapidly absorbed exclusively metabolized by the liver metabolism and 13C would be measured in exhaled breath within 20-30 minutes Hepatic metabolism of the compound is assessed by measuring the ratio of 13C12C in exhaled breath The ability to detect differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the BreathID collection system and analyzer unit
The compound selected for this study will be 13C-methacetin Methacetin meets all of the qualifications for an excellent substrate for liver breath tests It is a non-toxic small molecule 13C can be synthesized into a key location within this agent It can be administered orally in solution It is rapidly absorbed and metabolized by hepatic microsomes and this process releases CO2 as a by-product in exhaled breath No reports of any complications or side effects using this substance have been reported
13C-methacetin is rapidly absorbed and metabolized by healthy liver cells into acetaminophen and 13CO2 The resultant CO2 can be measured in the exhaled breath The amount of metabolized methacetin indicates the capability of the liver to accomplish one of its main physiological tasks and has been shown to correlate with liver fibrosis and cirrhosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None