Trial Outcomes & Findings for Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17 (NCT NCT03462576)
NCT ID: NCT03462576
Last Updated: 2022-12-20
Results Overview
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 5.5%/hour. The data was collected and analyzed agnostic to the intervention.
Recruitment status
TERMINATED
Target enrollment
199 participants
Primary outcome timeframe
1 hour for MBT for assessment of this diagnostic outcome assessed during screening
Results posted on
2022-12-20
Participant Flow
60 subjects were disqualified at baseline before being divided into arms due to screen failure.
Participant milestones
| Measure |
Patients With Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm .
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
48
|
45
|
|
Overall Study
COMPLETED
|
41
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
8
|
Reasons for withdrawal
| Measure |
Patients With Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm .
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
11
|
7
|
|
Overall Study
Device Malfunction
|
0
|
0
|
1
|
Baseline Characteristics
1 subject's test was discontinued due to device malfunction.
Baseline characteristics by cohort
| Measure |
Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
n=46 Participants
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
n=48 Participants
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
n=45 Participants
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm .
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.674 years
STANDARD_DEVIATION 9.307 • n=46 Participants • 1 subject's test was discontinued due to device malfunction.
|
60.875 years
STANDARD_DEVIATION 8.668 • n=48 Participants • 1 subject's test was discontinued due to device malfunction.
|
62.864 years
STANDARD_DEVIATION 7.135 • n=44 Participants • 1 subject's test was discontinued due to device malfunction.
|
61.1 years
STANDARD_DEVIATION 8.48 • n=138 Participants • 1 subject's test was discontinued due to device malfunction.
|
|
Sex: Female, Male
Female
|
26 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
19 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
27 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
72 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Sex: Female, Male
Male
|
20 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
29 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
17 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
66 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
1 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
1 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
3 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
2 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
1 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
3 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
White
|
43 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
43 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
41 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
127 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
2 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
1 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
4 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
0 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
1 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
|
Region of Enrollment
United States
|
46 Participants
n=46 Participants • 1 subject test was discontinued due to device malfunction.
|
48 Participants
n=48 Participants • 1 subject test was discontinued due to device malfunction.
|
44 Participants
n=44 Participants • 1 subject test was discontinued due to device malfunction.
|
138 Participants
n=138 Participants • 1 subject test was discontinued due to device malfunction.
|
PRIMARY outcome
Timeframe: 1 hour for MBT for assessment of this diagnostic outcome assessed during screeningPopulation: The population analyzed is Intent to Diagnose (ITD)
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 5.5%/hour. The data was collected and analyzed agnostic to the intervention.
Outcome measures
| Measure |
Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
n=46 Participants
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
n=48 Participants
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
n=44 Participants
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm.
|
|---|---|---|---|
|
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
Events in subjects below cut-off
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
No event recorded in subjects below cut-off
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
Events in subjects above cut-off
|
15 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
No event recorded in subjects above cut-off
|
27 Participants
|
28 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 hour for MBT for assessment of this diagnostic outcome assessed during screeningPopulation: The population analyzed is Intent to Diagnose (ITD).
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 7.5%/hour.The data was collected and analyzed agnostic to the intervention.
Outcome measures
| Measure |
Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
n=46 Participants
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
n=48 Participants
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
n=44 Participants
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm.
|
|---|---|---|---|
|
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
Events in subjects below cut-off
|
4 Participants
|
8 Participants
|
9 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
No event recorded in subjects below cut-off
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
Events in subjects above cut-off
|
14 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
No event recorded in subjects above cut-off
|
24 Participants
|
26 Participants
|
21 Participants
|
Adverse Events
Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Number of Subjects Experiencing a High Risk Event in Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm
n=46 participants at risk
Arm 1. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 25 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm
n=48 participants at risk
Arm 2. The number of subjects that experience a decompensation event as described in the protocol in the arm treated with 5 mg of Emricasan.
|
Number of Subjects Experiencing a High Risk Event in Placebo Arm
n=45 participants at risk
Arm 3. The number of subjects that experience a decompensation event as described in the protocol in the placebo arm.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
URI
|
0.00%
0/46 • Adverse event data was collected for a period of 48 weeks
|
2.1%
1/48 • Number of events 1 • Adverse event data was collected for a period of 48 weeks
|
0.00%
0/45 • Adverse event data was collected for a period of 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected for a period of 48 weeks
|
0.00%
0/48 • Adverse event data was collected for a period of 48 weeks
|
0.00%
0/45 • Adverse event data was collected for a period of 48 weeks
|
Additional Information
Avrahm Hershkowitz/ Clinical Trial Manager
Exalenz Bioscience
Phone: 972-8-9737513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place