Phase 2
N=30
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Portal Hypertension · Liver Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT02802228 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Jan 2022
Primary outcome: Primary: Safety (Incidence and Severity of Adverse Events) — 23; 2 Number of adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ifetroban (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Incidence and Severity of Adverse Events) |
23; 2 | — |
| PRIMARY Safety (Severity of Adverse Events) |
11; 1; 8; 0; 4; 1 | — |
| SECONDARY Change in Hepatic Venous Pressure Gradient (HVPG) |
1.6; -0.1 | — |
| SECONDARY Change in Aspartate Aminotransferase (AST) |
-1.2; 4.2 | — |
| SECONDARY Alanine Aminotransferase (ALT) |
-4.8; 2.2 | — |
| SECONDARY Aspartate Aminotransferase/Platelet Ratio (APRI) |
0.84; 0.98 | — |
| SECONDARY Variceal Bleeds (Occurrence of Variceal Bleeds) |
0; 1 | — |
Summary
This placebo-controlled study will assess the safety and efficacy of a 90-day course of treatment with ifetroban for portal hypertension in cirrhotic patients
Eligibility Criteria
Inclusion Criteria
- liver cirrhosis
- baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and = 12
- Model for End-stage Liver Disease- Sodium score (MELD-Na) >= 20
- Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL
- current alcohol consumption > 2 drinks per day
- Platelet count (PLT) < 60 x 10^3/microliter (uL)
- A change in statin therapy in the last 3 months
- Current Hepatitis Virus B or C (HBV or HCV) therapy; or planned initiation of therapy during the treatment period
- Myocardial infarction within 30 days
- History of bleeding diathesis or current (within previous 14 days) or planned use of anticoagulant or antiplatelet drugs including aspirin
Data sourced from ClinicalTrials.gov (NCT02802228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.