Trial Outcomes & Findings for Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients (NCT NCT02802228)
NCT ID: NCT02802228
Last Updated: 2022-01-19
Results Overview
Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Through 97 days (90 days treatment and 7 days follow-up)
Results posted on
2022-01-19
Participant Flow
Participant milestones
| Measure |
Ifetroban
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
15
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Ifetroban
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Baseline characteristics by cohort
| Measure |
Ifetroban
n=20 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Hepatitis B only
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Hepatitis C only
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Hepatitis B and C
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Non-alcoholic Steatohepatitis
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Alcoholic
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Auto-immune
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary Cirrhosis Etiology
Cryptogenic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 97 days (90 days treatment and 7 days follow-up)Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group.
Outcome measures
| Measure |
Ifetroban
n=20 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Safety (Incidence and Severity of Adverse Events)
|
23 Number of adverse events
|
2 Number of adverse events
|
PRIMARY outcome
Timeframe: Through 90 days treatment and 7 days follow-upThe severity of each event is reported by the investigator according to the following protocol/CTCAE definitions: Grade 1-Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2-Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3-Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4-Life-threatening consequences; urgent intervention indicated; Grade 5-Death related to adverse event.
Outcome measures
| Measure |
Ifetroban
n=23 Adverse Events
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=2 Adverse Events
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Safety (Severity of Adverse Events)
Grade 1 (mild)
|
11 Adverse Events
|
1 Adverse Events
|
|
Safety (Severity of Adverse Events)
Grade 2 (moderate)
|
8 Adverse Events
|
0 Adverse Events
|
|
Safety (Severity of Adverse Events)
Greade 3 (severe)
|
4 Adverse Events
|
1 Adverse Events
|
|
Safety (Severity of Adverse Events)
Grade 4 (life-threatening)
|
0 Adverse Events
|
0 Adverse Events
|
|
Safety (Severity of Adverse Events)
Grade 5 (death)
|
0 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: Baseline and 90 daysThe HVPG will be measured through Day 90 and will be compared to baseline
Outcome measures
| Measure |
Ifetroban
n=15 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Change in Hepatic Venous Pressure Gradient (HVPG)
|
1.6 mmHg
Standard Deviation 3.7
|
-0.1 mmHg
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison.
AST values through Day 90 will be compared to baseline
Outcome measures
| Measure |
Ifetroban
n=17 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Change in Aspartate Aminotransferase (AST)
|
-1.2 U/L
Standard Deviation 9.1
|
4.2 U/L
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison.
ALT values through Day 90 will be compared to baseline
Outcome measures
| Measure |
Ifetroban
n=17 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Alanine Aminotransferase (ALT)
|
-4.8 U/L
Standard Deviation 7.4
|
2.2 U/L
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison.
The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline
Outcome measures
| Measure |
Ifetroban
n=16 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Aspartate Aminotransferase/Platelet Ratio (APRI)
|
0.84 ratio
Standard Deviation 0.52
|
0.98 ratio
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Through Day 97The number of variceal bleeds during the treatment and follow-up periods will be evaluated
Outcome measures
| Measure |
Ifetroban
n=20 Participants
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 Participants
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Variceal Bleeds (Occurrence of Variceal Bleeds)
|
0 events of variceal bleeding
|
1 events of variceal bleeding
|
Adverse Events
Ifetroban
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ifetroban
n=20 participants at risk
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 participants at risk
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Hepatobiliary disorders
Ascites
|
5.0%
1/20 • Number of events 2 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Hepatobiliary disorders
oesophageal varices haemorrhage
|
0.00%
0/20 • 90 days of investigational treatment and 7 days of follow-up
|
10.0%
1/10 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
Other adverse events
| Measure |
Ifetroban
n=20 participants at risk
90 day course of oral ifetroban following intravenous loading dose
Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
|
Placebo
n=10 participants at risk
90 day course of placebo following intravenous dose of D5W
Placebo: matched placebo delivered as infusion and oral capsule
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Blood and lymphatic system disorders
Eccymosis
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
10.0%
1/10 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
|
Blood and lymphatic system disorders
Petechiae
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
10.0%
1/10 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
|
Gastrointestinal disorders
Dental discomfort
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
General disorders
Peripheral swelling
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Immune system disorders
Subacute cutaneous lupus erythematosus
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Investigations
Thromboelastogram
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Nervous system disorders
Migraine
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Nervous system disorders
Vertigo positional
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Number of events 1 • 90 days of investigational treatment and 7 days of follow-up
|
0.00%
0/10 • 90 days of investigational treatment and 7 days of follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60