Trial Outcomes & Findings for BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH (NCT NCT02314026)

NCT ID: NCT02314026

Last Updated: 2022-12-20

Results Overview

Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 140 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-12-20

Participant Flow

Participant milestones

Measure	Suspected NASH 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Overall Study STARTED	135
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Measure	Suspected NASH 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Overall Study Protocol Violation	28

Baseline Characteristics

BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH

Baseline characteristics by cohort

Measure	Suspected NASH n=135 Participants 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Age, Continuous	53.4 years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Belgium	15 participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants
Region of Enrollment France	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Subjects that had a valid biopsy and performed both Octanoate and Methacetin Breath test

Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator

Outcome measures

Measure	Suspected NASH n=107 Participants 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis Definite NASH	74 Participants
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis Probable NASH	20 Participants
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis Absent of NASH	13 Participants

PRIMARY outcome

Timeframe: 36 months

Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.

Outcome measures

Measure

Suspected NASH n=107 Participants 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Liver Decompensation as Measured by Area Under Receiver Operating Curve

0.852 Probability Interval 0.771 to 0.933

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours from last breath test

A phone call will be made to each subject 48 hours after the last breath test to confirm that no adverse events related to breath test have been experienced.

Outcome measures

Measure	Suspected NASH n=135 Participants 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Number of Participants With Adverse Events Possibly related adverse event	0 Participants
Number of Participants With Adverse Events No possibly related reported adverse events	135 Participants

Adverse Events

Suspected NASH

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure

Suspected NASH n=135 participants at risk 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Hepatobiliary disorders Acute cholecystitis

0.74% 1/135 • Number of events 1 • Adverse events were collected for up to 36 months from enrollment

Other adverse events

Measure	Suspected NASH n=135 participants at risk 13C-Octanoate, 13C-Methacetin Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
Gastrointestinal disorders Abdominal pain	0.74% 1/135 • Number of events 1 • Adverse events were collected for up to 36 months from enrollment
Gastrointestinal disorders Nausea	1.5% 2/135 • Number of events 2 • Adverse events were collected for up to 36 months from enrollment
Nervous system disorders Dizziness	0.74% 1/135 • Number of events 1 • Adverse events were collected for up to 36 months from enrollment
Nervous system disorders Headache	0.74% 1/135 • Number of events 1 • Adverse events were collected for up to 36 months from enrollment

Additional Information

Clinical trial manager

Exalenz Bioscience

Phone: 97289737513

Email: avrahamh@exalenz.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60