Trial Outcomes & Findings for Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation (NCT NCT02084160)

Results Overview

Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: 1. Death (liver related) 2. Transplantation (cadaveric and living donors) 3. Ascites 4. HE (Hepatic Encephalopathy) 5. Newly diagnosed varices or variceal bleeding 6. SBP (spontaneous bacterial peritonitis) 7. HRS (Hepatorenal syndrome) 8. HCC (hepatocellular carcinoma) 9. Increase in CTP (Child Turcotte Pugh) Score by 3 points 10. Increase in MELD score by 5 points

Recruitment status

COMPLETED

Target enrollment

579 participants

Primary outcome timeframe

5 years

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	CLD From HIS-EX-408/PLT-BID-1108 Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108
Overall Study STARTED	579
Overall Study COMPLETED	579
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLD From HIS-EX-408/PLT-BID-1108 n=579 Participants Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108
Age, Continuous	52.55 years STANDARD_DEVIATION 10.67 • n=579 Participants
Sex: Female, Male Female	237 Participants n=579 Participants
Sex: Female, Male Male	342 Participants n=579 Participants
Region of Enrollment United States	418 Participants n=579 Participants
Region of Enrollment Israel	161 Participants n=579 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Patients with advanced chronic liver disease

Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: 1. Death (liver related) 2. Transplantation (cadaveric and living donors) 3. Ascites 4. HE (Hepatic Encephalopathy) 5. Newly diagnosed varices or variceal bleeding 6. SBP (spontaneous bacterial peritonitis) 7. HRS (Hepatorenal syndrome) 8. HCC (hepatocellular carcinoma) 9. Increase in CTP (Child Turcotte Pugh) Score by 3 points 10. Increase in MELD score by 5 points

Outcome measures

Outcome measures
Measure	CLD From HIS-EX-408/PLT-BID-1108 n=579 Participants Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108
Hepatic Decompensation Event	324 number of events

Adverse Events

CLD From HIS-EX-408/PLT-BID-1108

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Avrahm Hershkowitz/ Clinical Trial Manager

Exalenz

Phone: 972-8-9737500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place