Trial Outcomes & Findings for Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment (NCT NCT04480827)
NCT ID: NCT04480827
Last Updated: 2024-08-14
Results Overview
AUC from time 0 to the dosing interval tau measured at steady state. Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
Day 12
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2- Moderate Hepatic Impairment Cohort
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
15
|
4
|
7
|
7
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
15
|
4
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2- Moderate Hepatic Impairment Cohort
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
Baseline characteristics by cohort
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 Participants
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 Participants
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 Participants
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 Participants
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
n=4 Participants
4 mild hepatic impaired subjects (mild, moderate or severe)
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Hepatic Impairment Cohort
n=7 Participants
7 moderate hepatic impaired subjects (mild, moderate or severe)
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
n=7 Participants
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=15 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
57 Participants
n=57 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=57 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=15 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
39 Participants
n=57 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=15 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=57 Participants
|
|
Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 8.10 • n=8 Participants
|
63.3 Years
STANDARD_DEVIATION 9.02 • n=8 Participants
|
62.0 Years
STANDARD_DEVIATION 6.35 • n=8 Participants
|
59.7 Years
STANDARD_DEVIATION 8.50 • n=15 Participants
|
64.0 Years
STANDARD_DEVIATION 4.16 • n=4 Participants
|
60.1 Years
STANDARD_DEVIATION 8.47 • n=7 Participants
|
60.1 Years
STANDARD_DEVIATION 6.82 • n=7 Participants
|
60.86 Years
STANDARD_DEVIATION 7.63 • n=57 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=15 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
11 Participants
n=15 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
41 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=15 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
44 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=15 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=57 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=15 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
46 Participants
n=57 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=57 Participants
|
|
Child-Pugh total scores
|
5.38 points
STANDARD_DEVIATION 0.518 • n=8 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
8.25 points
STANDARD_DEVIATION 0.886 • n=8 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
11.50 points
STANDARD_DEVIATION 1.512 • n=8 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
—
|
5.75 points
STANDARD_DEVIATION 0.5 • n=4 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
7.71 points
STANDARD_DEVIATION 0.756 • n=7 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
—
|
7.94 points
STANDARD_DEVIATION 2.25 • n=35 Participants • Healthy volunteers don't have any meaningful disease, and thus they don't have any liver disease or liver issues and as a result they don't have a Child-Pugh score
|
PRIMARY outcome
Timeframe: Day 12AUC from time 0 to the dosing interval tau measured at steady state. Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Outcome measures
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 Participants
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 Participants
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 Participants
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 Participants
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
n=4 Participants
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Impairment Cohort
n=7 Participants
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
n=7 Participants
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
AUC0-tau, Steady State
|
96100 h•ng/mL
Geometric Coefficient of Variation 138.29
|
107000 h•ng/mL
Geometric Coefficient of Variation 154.13
|
103000 h•ng/mL
Geometric Coefficient of Variation 148.09
|
69500 h•ng/mL
Geometric Coefficient of Variation 0
|
63300 h•ng/mL
Geometric Coefficient of Variation 4.3
|
55900 h•ng/mL
Geometric Coefficient of Variation 31.4
|
61400 h•ng/mL
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: Day 12Maximum plasma concentrations (Cmax,ss) Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Outcome measures
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 Participants
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 Participants
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 Participants
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 Participants
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
n=4 Participants
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Impairment Cohort
n=7 Participants
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
n=7 Participants
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Cmax,ss
|
1950 ng/mL
Geometric Coefficient of Variation 138.17
|
1890 ng/mL
Geometric Coefficient of Variation 134.26
|
1480 ng/mL
Geometric Coefficient of Variation 105.22
|
1410 ng/mL
Geometric Coefficient of Variation 0
|
5750 ng/mL
Geometric Coefficient of Variation 5.2
|
5380 ng/mL
Geometric Coefficient of Variation 26.1
|
6040 ng/mL
Geometric Coefficient of Variation 21.3
|
PRIMARY outcome
Timeframe: Day 11Population: Note that apparent total oral clearance data was analyzed for Part 1 only, where comparison was made between Healthy volunteers and Hepatic impairment patients. Such data was not collected and analyzed for Part 2
CL/F measured after single dose in Part 1 Blood was collected at the following time points: before dosing (0 hour) and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 48, 72, 96, 120, 144, 168, 192, and 240 hours
Outcome measures
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 Participants
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 Participants
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 Participants
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 Participants
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Impairment Cohort
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Oral Clearance, Single Dose
|
5.96 L/h
Geometric Coefficient of Variation 43.8
|
5.23 L/h
Geometric Coefficient of Variation 29.2
|
5.86 L/h
Geometric Coefficient of Variation 52.5
|
8.01 L/h
Geometric Coefficient of Variation 50.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: up to 22 days; Part 2: up to 27 daysPopulation: All subjects
The number of significant treatment-related adverse events
Outcome measures
| Measure |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 Participants
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 Participants
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 Participants
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 Participants
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
n=4 Participants
4 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Impairment Cohort
n=7 Participants
7 hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
n=7 Participants
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Significant TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1: Mild Hepatic Impairment (Cohort A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Moderate Hepatic Impairment (Cohort B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Severe Hepatic Impairment (Cohort C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Healthy Volunteers (Cohort D)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Mild Hepatic Impairment Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Moderate Impairment Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Healthy Volunteers Cohort
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 |
Part 1: Mild Hepatic Impairment (Cohort A)
n=8 participants at risk
8 mild hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Moderate Hepatic Impairment (Cohort B)
n=8 participants at risk
8 moderate hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Severe Hepatic Impairment (Cohort C)
n=8 participants at risk
8 severe hepatic impaired subjects
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 1: Healthy Volunteers (Cohort D)
n=15 participants at risk
15 matched healthy volunteers
Aramchol 600mg single dose: aramchol acid tablet 600mg, single dose
|
Part 2: Mild Hepatic Impairment Cohort
n=4 participants at risk
4 mild hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Moderate Impairment Cohort
n=7 participants at risk
7 moderate hepatic impaired subjects
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
Part 2: Healthy Volunteers Cohort
n=7 participants at risk
7 matched healthy volunteers
Aramchol 300mg, bid: aramchol acid tablet 300mg, bid for 12 days
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
0.00%
0/8 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
0.00%
0/8 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
0.00%
0/15 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
0.00%
0/4 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
0.00%
0/7 • Adverse events were assessed from the time the subject signed the informed consent until study completion (i.e., End of study- 30 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place