Trial Outcomes & Findings for Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures (NCT NCT02389621)
NCT ID: NCT02389621
Last Updated: 2018-10-30
Results Overview
Participants were considered as meeting the primary endpoint if all of the following conditions were satisfied: * Required no platelet transfusion from the date of randomization through at least 7 days after the primary invasive procedure * Did not receive the following rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure * Platelet preparations * Other blood preparations, including red blood cells and plasma * Volume expanders * Underwent an invasive procedure. Participants who received at least one platelet transfusion prior to the primary invasive procedure, received at least one rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure, discontinued from the study before undergoing the primary invasive procedure, or did not undergo an invasive procedure were considered as not meeting the primary endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
215 participants
Primary outcome timeframe
From Randomization to 7 days after the invasive procedure, up to approximately 21 days.
Results posted on
2018-10-30
Participant Flow
The study was conducted at 138 sites in 22 countries (Argentina, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, and United States of America).
The study consisted of a screening period (up to 28 days), a treatment period of 7 days, and a posttreatment period (through 28 days posttreatment). Randomization was stratified by the primary invasive procedure (ie, liver ablation/coagulation or other invasive procedures) and baseline platelet count (\< 35 × 10⁹/L or ≥ 35 × 10⁹/L).
Participant milestones
| Measure |
Lusutrombopag
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
|---|---|---|
|
Treatment Period
STARTED
|
108
|
107
|
|
Treatment Period
Received Study Drug
|
107
|
107
|
|
Treatment Period
COMPLETED
|
107
|
106
|
|
Treatment Period
NOT COMPLETED
|
1
|
1
|
|
Posttreatment Period
STARTED
|
107
|
106
|
|
Posttreatment Period
COMPLETED
|
98
|
102
|
|
Posttreatment Period
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Lusutrombopag
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
|---|---|---|
|
Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Posttreatment Period
Adverse Event
|
3
|
1
|
|
Posttreatment Period
Withdrawal by Subject
|
3
|
2
|
|
Posttreatment Period
Lost to Follow-up
|
1
|
1
|
|
Posttreatment Period
Other - Miscellaneous
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
Baseline characteristics by cohort
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not provided
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Planned Invasive Procedure
Liver ablation/ coagulation
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Planned Invasive Procedure
Other
|
101 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Baseline Platelet Count
< 35 × 10⁹/L
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Baseline Platelet Count
≥ 35 × 10⁹/L
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Baseline Platelet Count
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Randomization to 7 days after the invasive procedure, up to approximately 21 days.Population: All randomized participants (intent-to-treat population)
Participants were considered as meeting the primary endpoint if all of the following conditions were satisfied: * Required no platelet transfusion from the date of randomization through at least 7 days after the primary invasive procedure * Did not receive the following rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure * Platelet preparations * Other blood preparations, including red blood cells and plasma * Volume expanders * Underwent an invasive procedure. Participants who received at least one platelet transfusion prior to the primary invasive procedure, received at least one rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure, discontinued from the study before undergoing the primary invasive procedure, or did not undergo an invasive procedure were considered as not meeting the primary endpoint.
Outcome measures
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Percentage of Participants Who Required No Platelet Transfusion Prior to the Primary Invasive Procedure and No Rescue Therapy For Bleeding From Randomization Through 7 Days After the Primary Elective Procedure
|
64.8 percentage of participants
Interval 55.0 to 73.8
|
29.0 percentage of participants
Interval 20.6 to 38.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to end of the posttreatment period, 35 days.Population: All randomized participants (intent-to-treat population)
Participants who did not undergo the invasive procedure were considered as having received platelet transfusion.
Outcome measures
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Percentage of Participants Who Required no Platelet Transfusion During the Study
|
63.0 percentage of participants
Interval 53.1 to 72.1
|
29.0 percentage of participants
Interval 20.6 to 38.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to the end of the posttreatment period, 35 days.Population: All randomized participants (intent-to-treat population)
A response was defined as a platelet count of ≥ 50 × 10⁹/L with an increase of ≥ 20 × 10⁹/L from Baseline at any time during the study. Participants who met this response criterion only after platelet transfusion were considered as nonresponders.
Outcome measures
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Percentage of Participants With a Response
|
64.8 percentage of participants
Interval 55.0 to 73.8
|
13.1 percentage of participants
Interval 7.3 to 21.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to the end of the posttreatment period, 35 days.Population: All randomized participants with available data
The duration of the increase in platelet count was defined as the number of days during which the platelet count was maintained as ≥ 50 × 10⁹/L.
Outcome measures
| Measure |
Lusutrombopag
n=107 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L
|
15.11 days
Interval 6.59 to 23.88
|
0.98 days
Interval 0.0 to 9.22
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to the end of the posttreatment period, 35 days.Population: All randomized participants with available data
The duration of the increase in platelet count was defined as the number of days during which the platelet count was maintained as ≥ 50 × 10⁹/L.
Outcome measures
| Measure |
Lusutrombopag
n=34 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=73 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
n=73 Participants
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
n=34 Participants
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L by Platelet Transfusion Status
|
1.73 days
Interval 0.0 to 14.0
|
19.21 days
Interval 12.64 to 28.0
|
0.00 days
Interval 0.0 to 5.04
|
8.86 days
Interval 0.0 to 18.73
|
SECONDARY outcome
Timeframe: From Day 1 to the end of the possttreatment period, 35 days.Population: All randomized participants (intent-to-treat population)
Participants who received rescue therapy for bleeding events during the study. Platelet preparations, other blood preparations (including red blood cells and plasma), and volume expanders were considered as rescue therapy for bleeding events.
Outcome measures
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study
|
0.0 percentage of participants
|
1.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to the end of the posttreatment period, 35 days.Population: All randomized participants (intent-to-treat population)
The number of transfusions administered to each patient were collected over the duration of the trial. The data are presented as the number of patients with the highest total number of transfusions followed by the next highest number of transfusions, etc.
Outcome measures
| Measure |
Lusutrombopag
n=108 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Number of Participants With Specified Total Number of Platelet Transfusions
One transfusion
|
34 Participants
|
61 Participants
|
—
|
—
|
|
Number of Participants With Specified Total Number of Platelet Transfusions
No transfusions
|
74 Participants
|
34 Participants
|
—
|
—
|
|
Number of Participants With Specified Total Number of Platelet Transfusions
Two transfusions
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Specified Total Number of Platelet Transfusions
Three transfusions
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Specified Total Number of Platelet Transfusions
Four transfusions
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Specified Total Number of Platelet Transfusions
Five transfusions
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 5, 6, 7, 8, 10, 12, 14, 17, 21, 28, and 35.Population: All randomized participants with available data at each time point.
Outcome measures
| Measure |
Lusutrombopag
n=34 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=74 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
n=73 Participants
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
n=34 Participants
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Change From Baseline in Platelet Count Over Time
Day 5
|
1.1 * 10⁹/L
Standard Deviation 6.5
|
10.4 * 10⁹/L
Standard Deviation 12.5
|
0.4 * 10⁹/L
Standard Deviation 6.6
|
6.1 * 10⁹/L
Standard Deviation 11.8
|
|
Change From Baseline in Platelet Count Over Time
Day 6
|
5.1 * 10⁹/L
Standard Deviation 8.1
|
13.6 * 10⁹/L
Standard Deviation 15.7
|
-0.6 * 10⁹/L
Standard Deviation 7.0
|
6.7 * 10⁹/L
Standard Deviation 12.4
|
|
Change From Baseline in Platelet Count Over Time
Day 7
|
4.7 * 10⁹/L
Standard Deviation 7.9
|
20.6 * 10⁹/L
Standard Deviation 16.8
|
0.0 * 10⁹/L
Standard Deviation 7.7
|
6.7 * 10⁹/L
Standard Deviation 12.9
|
|
Change From Baseline in Platelet Count Over Time
Day 8
|
7.7 * 10⁹/L
Standard Deviation 9.5
|
27.4 * 10⁹/L
Standard Deviation 21.5
|
-0.1 * 10⁹/L
Standard Deviation 5.2
|
7.3 * 10⁹/L
Standard Deviation 13.5
|
|
Change From Baseline in Platelet Count Over Time
Day 10
|
12.6 * 10⁹/L
Standard Deviation 10.6
|
36.7 * 10⁹/L
Standard Deviation 24.1
|
2.1 * 10⁹/L
Standard Deviation 11.0
|
12.7 * 10⁹/L
Standard Deviation 20.6
|
|
Change From Baseline in Platelet Count Over Time
Day 12
|
15.4 * 10⁹/L
Standard Deviation 12.3
|
37.0 * 10⁹/L
Standard Deviation 18.5
|
3.1 * 10⁹/L
Standard Deviation 9.5
|
14.8 * 10⁹/L
Standard Deviation 24.0
|
|
Change From Baseline in Platelet Count Over Time
Day 14
|
17.3 * 10⁹/L
Standard Deviation 19.3
|
33.5 * 10⁹/L
Standard Deviation 19.9
|
4.0 * 10⁹/L
Standard Deviation 11.8
|
12.8 * 10⁹/L
Standard Deviation 28.1
|
|
Change From Baseline in Platelet Count Over Time
Day 17
|
17.1 * 10⁹/L
Standard Deviation 23.4
|
27.2 * 10⁹/L
Standard Deviation 21.1
|
1.9 * 10⁹/L
Standard Deviation 9.0
|
17.0 * 10⁹/L
Standard Deviation 27.7
|
|
Change From Baseline in Platelet Count Over Time
Day 21
|
9.8 * 10⁹/L
Standard Deviation 16.0
|
20.9 * 10⁹/L
Standard Deviation 20.3
|
2.5 * 10⁹/L
Standard Deviation 9.0
|
13.2 * 10⁹/L
Standard Deviation 20.7
|
|
Change From Baseline in Platelet Count Over Time
Day 28
|
1.7 * 10⁹/L
Standard Deviation 11.4
|
12.4 * 10⁹/L
Standard Deviation 18.8
|
2.0 * 10⁹/L
Standard Deviation 8.9
|
10.1 * 10⁹/L
Standard Deviation 17.6
|
|
Change From Baseline in Platelet Count Over Time
Day 35
|
-1.3 * 10⁹/L
Standard Deviation 6.2
|
9.4 * 10⁹/L
Standard Deviation 19.3
|
0.7 * 10⁹/L
Standard Deviation 9.1
|
6.0 * 10⁹/L
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: From first dose of study drug to 28 days after the last dose, 35 days.Population: All randomized participants who received at least 1 dose of the study drug.
Outcome measures
| Measure |
Lusutrombopag
n=107 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 Participants
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Adverse events with outcome of death
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation of study drug
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related adverse events
|
6 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
All adverse events
|
51 Participants
|
52 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
7 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).Population: Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.
Outcome measures
| Measure |
Lusutrombopag
n=9 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Lusutrombopag
|
157 ng/mL
Geometric Coefficient of Variation 34.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).Population: Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.
Outcome measures
| Measure |
Lusutrombopag
n=9 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Lusutrombopag
|
5.95 hours
Interval 2.03 to 7.85
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).Population: Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.
Outcome measures
| Measure |
Lusutrombopag
n=9 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) for Lusutrombopag
|
2737 ng*hr/mL
Geometric Coefficient of Variation 36.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).Population: Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.
Outcome measures
| Measure |
Lusutrombopag
n=9 Participants
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
Placebo once daily for up to 7 days.
|
Placebo With Platelet Transfusion
Placebo once daily for up to 7 days in participants who received platelet transfusion.
|
Placebo Without Platelet Transfusion
Placebo once daily for up to 7 days in participants who did not receive platelet transfusion.
|
|---|---|---|---|---|
|
Apparent Total Clearance (CL/F) of Lusutrombopag
|
1.10 L/h
Geometric Coefficient of Variation 36.1
|
—
|
—
|
—
|
Adverse Events
Lusutrombopag
Serious events: 7 serious events
Other events: 23 other events
Deaths: 3 deaths
Placebo
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lusutrombopag
n=107 participants at risk
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 participants at risk
Placebo once daily for up to 7 days.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Cardiac disorders
Cardiac arrest
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Vascular disorders
Vessel perforation
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
General disorders
Multiorgan failure
|
0.93%
1/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
Other adverse events
| Measure |
Lusutrombopag
n=107 participants at risk
Lusutrombopag 3 mg once daily for up to 7 days.
|
Placebo
n=107 participants at risk
Placebo once daily for up to 7 days.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
0.00%
0/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Nervous system disorders
Headache
|
5.6%
6/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
5/107 • From first dose of study drug until 28 days after last dose, 35 days
|
4.7%
5/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
3.7%
4/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Ascites
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
General disorders
Fatigue
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
6.5%
7/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
General disorders
Edema peripheral
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
3.7%
4/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
General disorders
Pyrexia
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.8%
3/107 • From first dose of study drug until 28 days after last dose, 35 days
|
1.9%
2/107 • From first dose of study drug until 28 days after last dose, 35 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER