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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
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
  Purpose

The three objectives of this trial are:

  1. 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.
  2. 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.
  3. 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:


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:

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

Exclusion Criteria:

  1. Known or suspected HCC
  2. Hepato-pulmonary syndrome
  3. Hepatorenal syndrome (creatinine > 2.5 mg/dl)
  4. Refractory ascites (More than 1 paracentesis within the preceding 3 months of enrollment. A single paracentesis performed for diagnostic purposes is not an exclusion)
  5. Hyponatremia
  6. Prior TIPS placement
  7. Prior episode of variceal hemorrhage
  8. MELD score >25
  9. Any patient whose expected time to liver transplantation is less than 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Department of Veteran Affairs
Richmond, Virginia, United States, 23249-0001
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Exalenz Bioscience LTD.
Virginia Commonwealth University
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:
Publications:

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
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 25, 2014