Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

This study has been terminated.

(Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz)

Sponsor:

Collaborators:

Virginia Commonwealth University

Department of Veterans Affairs

Hadassah Medical Organization

Information provided by:

Exalenz Bioscience LTD.

ClinicalTrials.gov Identifier:

NCT00375011

First received: September 10, 2006

Last updated: February 15, 2012

Last verified: February 2010

History of Changes

Purpose

The three objectives of this trial are:

To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis.
To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk to develop complications of cirrhosis.
To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk for liver related mortality.

The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and that thresholds can be established that will help predict risk of complications of cirrhosis and mortality.

Condition	Phase
Cirrhosis	Phase 3

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Use of the BreathID to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients With Cirrhosis in Need of Liver Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Liver Transplantation

U.S. FDA Resources

Further study details as provided by Exalenz Bioscience LTD.:

Estimated Enrollment:	200
Study Start Date:	September 2008
Study Completion Date:	October 2011

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Cirrhosis determined by liver histology or clinical findings

Criteria

Inclusion Criteria:

Cirrhosis determined by liver histology or clinical findings.
Age > 18 years

Exclusion Criteria:

Known or suspected HCC
Hepato-pulmonary syndrome
Hepatorenal syndrome (creatinine > 2.5 mg/dl)
Refractory ascites (More than 1 paracentesis within the preceding 3 months of enrollment. A single paracentesis performed for diagnostic purposes is not an exclusion)
Hyponatremia
Prior TIPS placement
Prior episode of variceal hemorrhage
MELD score >25
Any patient whose expected time to liver transplantation is less than 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375011

Locations

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Department of Veteran Affairs
Richmond, Virginia, United States, 23249-0001
Israel
Hadassah Medical Organization
Jerusalem, Israel

Sponsors and Collaborators

Exalenz Bioscience LTD.

Virginia Commonwealth University

Department of Veterans Affairs

Hadassah Medical Organization

Investigators

Principal Investigator:	Mitchell Shiffman, M.D.	Virginia Commonwealth University
Principal Investigator:	Douglas M Heuman, M.D.	Department of Veteran Affairs
Principal Investigator:	Maya Margalit, M.D.	Hadaassah Medical Organization

More Information

Additional Information:

Laboratory guidelines for screening, diagnosing and monitoring of hepatic injury This link exits the ClinicalTrials.gov site

BreathID (device used for study) website This link exits the ClinicalTrials.gov site

Publications:

Hoyert DL, Kung HC, Smith BL. Deaths: preliminary data for 2003. Natl Vital Stat Rep. 2005 Feb 28;53(15):1-48.

Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. Summary for patients in: Ann Intern Med. 2006 May 16;144(10):I20.

Said A, Williams J, Holden J, Remington P, Gangnon R, Musat A, Lucey MR. Model for end stage liver disease score predicts mortality across a broad spectrum of liver disease. J Hepatol. 2004 Jun;40(6):897-903.

Bambha K, Kim WR, Kremers WK, Therneau TM, Kamath PS, Wiesner R, Rosen CB, Thostenson J, Benson JT, Dickson ER. Predicting survival among patients listed for liver transplantation: an assessment of serial MELD measurements. Am J Transplant. 2004 Nov;4(11):1798-804.

Sanyal AJ, Banas C, Sargeant C, Luketic VA, Sterling RK, Stravitz RT, Shiffman ML, Heuman D, Coterrell A, Fisher RA, Contos MJ, Mills AS. Similarities and differences in outcomes of cirrhosis due to nonalcoholic steatohepatitis and hepatitis C. Hepatology. 2006 Apr;43(4):682-9.

Shiffman ML, Saab S, Feng S, Abecassis MI, Tzakis AG, Goodrich NP, Schaubel DE. Liver and intestine transplantation in the United States, 1995-2004. Am J Transplant. 2006;6(5 Pt 2):1170-87.

Festi D, Capodicasa S, Vestito A, Mazzella G, Roda E, Vitacolonna E, Petrolati A, Angelico M, Colecchia A. Breath tests with stable isotopes: have they a role in liver transplantation? Eur Rev Med Pharmacol Sci. 2004 Jan-Feb;8(1):55-8. Review.

Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85.

Festi D, Capodicasa S, Sandri L, Colaiocco-Ferrante L, Staniscia T, Vitacolonna E, Vestito A, Simoni P, Mazzella G, Portincasa P, Roda E, Colecchia A. Measurement of hepatic functional mass by means of 13C-methacetin and 13C-phenylalanine breath tests in chronic liver disease: comparison with Child-Pugh score and serum bile acid levels. World J Gastroenterol. 2005 Jan 7;11(1):142-8.

ClinicalTrials.gov Identifier:	NCT00375011 History of Changes
Other Study ID Numbers:	BID CIRR
Study First Received:	September 10, 2006
Last Updated:	February 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Exalenz Bioscience LTD.:

MELD-Model of End Stage Liver Disease score
CTP-Child-Turcotte-Pugh score
MEGX-monoethylglycinexylidide-resultant of metabolism of lidocaine

HCC-Hepatocellular carcinoma
HCV-Hepatitis C virus
NASH-Non-alcoholic Steatohepatitis

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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