TerminatedNot Applicable

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

Stopped: Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz

United States, Israel200 participantsStarted 2008-09

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

Trial details

NCT IDNCT00375011

SponsorMeridian Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

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