Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294489
Status:
UNKNOWN
Last Update Posted:
2006-02-22
First Post:
2006-02-21
Brief Title:
Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT
Status:
UNKNOWN
Status Verified Date:
2006-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A relatively large proportion of patients with chronic HCV infection have normal or mildly elevated ALT Many of these patients are not being treated and are not being sent for a liver biopsy The present study will determine the ability of Methcetin BreathID TestMBIT to detect those patients who will be candidates for anti-viral treatment as an alternative measure for liver biopsy in decision-making prior to treatment in clinical hepatology
Detailed Description:
The rational for using MBIT in the management of HCV in patients with persistently normal and slightly elevated ALT
If MBIT is impaired this indicates fibrosis 2 a trigger to begin treatment
This strategy will enable treating patients with relatively severe disease that was not detected by biopsy
HMOs recognize the cost-effectiveness of anti-viral therapy in these patients as a means of prevention of deterioration cirrhosis and HCC
If MBIT indicates low fibrosis treatment may be deferred and follow-up is performed to detect any possible degradation that will indicate need for treatment
Today the AASLD guidelines allow for treatment of HCV RNA patients with normal ALT In view of the limited effectivity of therapy its cost and side effects there are likely to be many individuals in whom therapy can be safely deferred leading to cost saving
MBIT may replace the need of liver biopsy for decision- making in HCV
Even in patients with genotype 1 and elevated ALT or with risk of side effects treatment may be delayed in low fibrosis eg 2
GOAL
To assess the ability of the MBIT to improve the management of patients for liver disorders
AIM
To determine whether the Methacetin BreathID Test MBIT can be useful in evaluation of HCV RNA positive patients with normal or minimally elevated ALT and to determine the severity of their liver disease as a guide for decision-making in routine clinical use
OBJECTIVE
AUC075 -10 in 95CI in detection of fibrosis2
INCLUSION CRITERIA
Men or women18
Patients with HCV RNA above 105 copies Patients with normal liver enzymes on two tests 3 months apart or up to X15 of upper normal
Patients with biopsy proven HCV or 9 months prior to test with no anticipated changes in liver disease since biopsy
EXCLUSION CRITERIA
Other liver disorders
Active infections
Use of drugs that are known to inducesuppress P4501A2
Pulmonary diseases
Consumption of 20cc alcohol a day prior to the test
NUMBER OF PATIENTS
200 HCV
50 matched controls
METHODS
Patient selection - All the patients that underwent a liver biopsy in the last 9 months in each center are invited to participate in the study assuming they meet inclusionexclusion criteria
Patients will undergo MBIT and data will be compared with the results of the different fibrotic and inflammatory scores ie METAVIR on liver biopsy One pathologist will re-examine all biopsies
Oridion BreathID will provide MBIT data on 50 healthy controls
Substrate - A test meal consisting of 75mg PO methacetin a known surface-active ingredient routinely used in the food and drug industry
Test length - 1 hour
Fasting-8 hours fast only
The patient will be attached to the BreathID device via a nasal cannula and after baseline breath is measured the test meal will be ingested and the device will continue measuring the exhaled breath for 1 hour The BreathID device automatically measures changes in the 13C12C ratio due to metabolization of the methacetin using a spectroscopic principal The results are printed out automatically at the end of the test
STUDY DESIGN
At first visit to physician patients will perform viral load test liver enzymes tests and MBIT A biopsy will have been performed within 9 months of these tests
If MBIT is impaired this indicates fibrosis 2 a trigger to begin treatment
This strategy will enable treating patients with relatively severe disease that was not detected by biopsy
HMOs recognize the cost-effectiveness of anti-viral therapy in these patients as a means of prevention of deterioration cirrhosis and HCC
If MBIT indicates low fibrosis treatment may be deferred and follow-up is performed to detect any possible degradation that will indicate need for treatment
Today the AASLD guidelines allow for treatment of HCV RNA patients with normal ALT In view of the limited effectivity of therapy its cost and side effects there are likely to be many individuals in whom therapy can be safely deferred leading to cost saving
MBIT may replace the need of liver biopsy for decision- making in HCV
Even in patients with genotype 1 and elevated ALT or with risk of side effects treatment may be delayed in low fibrosis eg 2
GOAL
To assess the ability of the MBIT to improve the management of patients for liver disorders
AIM
To determine whether the Methacetin BreathID Test MBIT can be useful in evaluation of HCV RNA positive patients with normal or minimally elevated ALT and to determine the severity of their liver disease as a guide for decision-making in routine clinical use
OBJECTIVE
AUC075 -10 in 95CI in detection of fibrosis2
INCLUSION CRITERIA
Men or women18
Patients with HCV RNA above 105 copies Patients with normal liver enzymes on two tests 3 months apart or up to X15 of upper normal
Patients with biopsy proven HCV or 9 months prior to test with no anticipated changes in liver disease since biopsy
EXCLUSION CRITERIA
Other liver disorders
Active infections
Use of drugs that are known to inducesuppress P4501A2
Pulmonary diseases
Consumption of 20cc alcohol a day prior to the test
NUMBER OF PATIENTS
200 HCV
50 matched controls
METHODS
Patient selection - All the patients that underwent a liver biopsy in the last 9 months in each center are invited to participate in the study assuming they meet inclusionexclusion criteria
Patients will undergo MBIT and data will be compared with the results of the different fibrotic and inflammatory scores ie METAVIR on liver biopsy One pathologist will re-examine all biopsies
Oridion BreathID will provide MBIT data on 50 healthy controls
Substrate - A test meal consisting of 75mg PO methacetin a known surface-active ingredient routinely used in the food and drug industry
Test length - 1 hour
Fasting-8 hours fast only
The patient will be attached to the BreathID device via a nasal cannula and after baseline breath is measured the test meal will be ingested and the device will continue measuring the exhaled breath for 1 hour The BreathID device automatically measures changes in the 13C12C ratio due to metabolization of the methacetin using a spectroscopic principal The results are printed out automatically at the end of the test
STUDY DESIGN
At first visit to physician patients will perform viral load test liver enzymes tests and MBIT A biopsy will have been performed within 9 months of these tests
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