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Trial Outcomes & Findings for Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14 (NCT NCT03439189)

NCT ID: NCT03439189

Last Updated: 2022-12-20

Results Overview

Binary diagnosis of clinically significant portal hypertension (CSPH) as determined by HVPG, defined as HVPG ≥ 10mmHg and by the MBT derived from an algorithm developed under other Exalenz clinical studies

Recruitment status

COMPLETED

Target enrollment

343 participants

Primary outcome timeframe

1 hour for MBT related to assessment of this diagnostic primary outcome assesses during screening

Results posted on

2022-12-20

Participant Flow

All subjects that met the companion protocol eligibility criteria were enrolled.

Diagnostic endpoints used screening measurements taken prior to study drug administration, therefore no treatment effect was relevant. In addition, for the event prediction endpoints, the treatment covariate was tested for significance, and was found to be non-significant, thus removed from the final predicting model. As such, arms were combined.

Participant milestones

Participant milestones
Measure
ACLD With NASH
Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
Overall Study
STARTED
343
Overall Study
COMPLETED
261
Overall Study
NOT COMPLETED
82

Reasons for withdrawal

Reasons for withdrawal
Measure
ACLD With NASH
Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
Overall Study
Protocol Violation
19
Overall Study
Lack of Efficacy
63

Baseline Characteristics

Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ACLD With NASH
n=343 Participants
Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
Age, Continuous
60.4 years
STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male
Female
200 Participants
n=5 Participants
Sex: Female, Male
Male
143 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
80 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
255 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
8 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
Race (NIH/OMB)
White
316 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants
n=5 Participants
Region of Enrollment
United States
309 participants
n=5 Participants
Region of Enrollment
France
10 participants
n=5 Participants
Region of Enrollment
Spain
24 participants
n=5 Participants
BMI
35.3 kg/cm^2
STANDARD_DEVIATION 7.07 • n=5 Participants
Compensated (Liver disease)
265 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 hour for MBT related to assessment of this diagnostic primary outcome assesses during screening

Population: Diagnostic endpoints used screening measurements taken prior to study drug administration, therefore no treatment effect was relevant. In addition, for the event prediction endpoints, the treatment covariate was tested for significance, and was found to be non-significant, thus removed from the final predicting model. As such, arms were combined.

Binary diagnosis of clinically significant portal hypertension (CSPH) as determined by HVPG, defined as HVPG ≥ 10mmHg and by the MBT derived from an algorithm developed under other Exalenz clinical studies

Outcome measures

Outcome measures
Measure
Subjects With CSPH
n=261 Participants
Subjects with Hepatic Venous Pressure Gradient (HVPG) equal to or greater than 10 mmHg
Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT)
190 Participants

SECONDARY outcome

Timeframe: 1 hour for MBT for assessment of this diagnostic secondary outcome assessed during screening

Population: Diagnostic endpoints used screening measurements taken prior to study drug administration, therefore no treatment effect was relevant. In addition, for the event prediction endpoints, the treatment covariate was tested for significance, and was found to be non-significant, thus removed from the final predicting model. As such, arms were combined.

Binary diagnosis of HVPG\>=12mmHg and by the MBT derived from an algorithm developed under other Exalenz clinical studies

Outcome measures

Outcome measures
Measure
Subjects With CSPH
n=261 Participants
Subjects with Hepatic Venous Pressure Gradient (HVPG) equal to or greater than 10 mmHg
Number of Matched Subjects With Significant Portal Hypertension (Defined as HVPG>=12mmHg) Based on HVPG and MBT
182 Participants

Adverse Events

ACLD With NASH

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
ACLD With NASH
n=343 participants at risk
Subjects with advanced chronic liver disease (ACLD) and confirmed nonalcoholic steatohepatitis (NASH)
Musculoskeletal and connective tissue disorders
Cramps
0.29%
1/343 • Number of events 1 • Data was collected for a duration of approximately 1 year to observe the effect of the treatment. Additional MBTs after 24 and 48 weeks were performed to enable Conatus to assess the ability of MBT to identify improvement in liver function due to treatment, if relevant. Each MBT duration is 1 hour. The subsequent MBTs were not relevant to companion protocol primary and secondary efficacy diagnostic endpoints listed above, but additional safety information regarding these MBTs was collected.
Diagnostic endpoints used screening measurements taken prior to study drug administration, therefore no treatment effect was relevant. In addition, for the event prediction endpoints, the treatment covariate was tested for significance, and was found to be non-significant, thus removed from the final predicting model. As such, arms were combined.
Gastrointestinal disorders
Diarrhea
0.29%
1/343 • Number of events 1 • Data was collected for a duration of approximately 1 year to observe the effect of the treatment. Additional MBTs after 24 and 48 weeks were performed to enable Conatus to assess the ability of MBT to identify improvement in liver function due to treatment, if relevant. Each MBT duration is 1 hour. The subsequent MBTs were not relevant to companion protocol primary and secondary efficacy diagnostic endpoints listed above, but additional safety information regarding these MBTs was collected.
Diagnostic endpoints used screening measurements taken prior to study drug administration, therefore no treatment effect was relevant. In addition, for the event prediction endpoints, the treatment covariate was tested for significance, and was found to be non-significant, thus removed from the final predicting model. As such, arms were combined.

Additional Information

Clinical trial manager

Exalenz Bioscience

Phone: 00 972 546605412

Results disclosure agreements

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