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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.
Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLD (chronic liver disease) | Other | Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| c13 methacetin solution with breath analyzer | Device | Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS) | "Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard. | Study day 1 after a 1 hour test |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ROC (Area Under Receiver Operating Characteristic Curve) | The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy. | At study day 1 after 1 hour test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Gordon, MD | Henry Ford Health System | Principal Investigator |
| Adrian Rueben, MD | Medical University of South Carolina | Principal Investigator |
| Gadi Lalazar, MD | Hadassah Medical Organization | Principal Investigator |
| Arun Sanyal, MD | Virginia Commonwealth University | Principal Investigator |
| Fred Poordad, MD | Cedars Sinai Health System | Principal Investigator |
| K Rajender Reddy, MD | University of Pennsylvania Health System | Principal Investigator |
| Zobair Younossi, MD | Inova Health Care Services | Principal Investigator |
| Arthur McCullough, MD | The Cleveland Clinic | Principal Investigator |
| John Vierling, MD | St. Luke's Episcopal Hospital, Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Henry Ford Health Sytem |
4 sites, 1 in Israel and 3 in the United States recruited most of the subjects. Patients with chronic liver disease and recent biopsies performed or planned were approached. Exclusion criteria focused mostly on issues that would affect accuracy of breath test.
414 subjects were collected in 11 sites; 8 in the United states and 3 in Israel. Recruitment began in August 2008 and was completed Sep 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLD (Chronic Liver Disease) | Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CLD (Chronic Liver Disease) | Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS) | "Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard. | The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis. | Posted | Aug 2010 | Number | Participants | Study day 1 after a 1 hour test |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLD (Chronic Liver Disease) | Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material) |
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Technical problems caused the termination of 2 subjects who did not complete breath test. Liver biopsy, 1 patient refused and others had signs of HCC thus disqualified.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Exalenz Bioscience | 972-8-9737500 | 513 | avrahamh@exalenz.com |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Alexander Fich, MD |
| Soroka University Medical Center |
| Principal Investigator |
| Eli Zuckerman, MD | Carmel Medical Center | Principal Investigator |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29435 | United States |
| St Luke's Episcopal Hospital, Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Inova Helath System | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298-0341 | United States |
| Soroka Medical Center | Beersheba | Israel |
| Carmel Medical Center | Haifa | Israel |
| Hadassah Medical Center | Jerusalem | 93000 | Israel |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | AUC of ROC (Area Under Receiver Operating Characteristic Curve) | The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Probability | At study day 1 after 1 hour test |
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| 0 |
| 414 |
| 0 |
| 414 |
Any manuscript, abstract or other publication or presentation of results or information arising from the study (including ancillary studies involving trial patients) must be prepared in conjunction with Exalenz. Such materials must be submitted to Exalenz for review and comment at least 30 days prior to submission for publication or presentation.