Clinical trial · Observational
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
Use of the BreathID to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients With Cirrhosis in Need of Liver Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDHoyert DL, Kung HC, Smith BL. Deaths: preliminary data for 2003. Natl Vital Stat Rep. 2005 Feb 28;53(15):1-48. PMID 15779680
- BACKGROUNDArmstrong 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. doi: 10.7326/0003-4819-144-10-200605160-00004. PMID 16702586
- BACKGROUNDSaid 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. doi: 10.1016/j.jhep.2004.02.010. PMID 15158328
- BACKGROUNDBambha 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. doi: 10.1111/j.1600-6143.2004.00550.x. PMID 15476479
- BACKGROUNDSanyal 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. doi: 10.1002/hep.21103. PMID 16502396
- BACKGROUNDShiffman 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. doi: 10.1111/j.1600-6143.2006.01273.x. PMID 16613594
- BACKGROUNDFesti 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.