Trial · NCT02802228
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
NCT02802228, Phase 2, Completed, Cumberland Pharmaceuticals; results first posted 2022-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients. Trials, record NCT02802228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02802228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
- NCT number
- NCT02802228
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Cumberland Pharmaceuticals
- Conditions
- Portal Hypertension, Liver Cirrhosis
- Interventions
- Ifetroban, Placebo
- First posted
- 2016-06-16
- Last updated
- 2022-01-19
- Results first posted
- 2022-01-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety (Incidence and Severity of Adverse Events) | 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. |
| Primary | Safety (Severity of Adverse Events) | Through 90 days treatment and 7 days follow-up | The 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. |
| Secondary | Change in Hepatic Venous Pressure Gradient (HVPG) | Baseline and 90 days | The HVPG will be measured through Day 90 and will be compared to baseline |
| Secondary | Change in Aspartate Aminotransferase (AST) | Baseline and 90 days | AST values through Day 90 will be compared to baseline |
| Secondary | Alanine Aminotransferase (ALT) | Baseline and 90 days | ALT values through Day 90 will be compared to baseline |
| Secondary | Aspartate Aminotransferase/Platelet Ratio (APRI) | Baseline and 90 days | The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline |
| Secondary | Variceal Bleeds (Occurrence of Variceal Bleeds) | Through Day 97 | The number of variceal bleeds during the treatment and follow-up periods will be evaluated |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety (Incidence and Severity of Adverse Events) | Through 97 days (90 days treatment and 7 days follow-up) | Number of adverse events | NUMBER | |
| PRIMARY | Safety (Severity of Adverse Events) | Through 90 days treatment and 7 days follow-up | Adverse Events | COUNT_OF_UNITS | |
| SECONDARY | Change in Hepatic Venous Pressure Gradient (HVPG) | Baseline and 90 days | mmHg | MEAN | |
| SECONDARY | Change in Aspartate Aminotransferase (AST) | Baseline and 90 days | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | U/L | MEAN |
| SECONDARY | Alanine Aminotransferase (ALT) | Baseline and 90 days | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | U/L | MEAN |
| SECONDARY | Aspartate Aminotransferase/Platelet Ratio (APRI) | Baseline and 90 days | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | ratio | MEAN |
| SECONDARY | Variceal Bleeds (Occurrence of Variceal Bleeds) | Through Day 97 | events of variceal bleeding | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety (Incidence and Severity of Adverse Events) | Ifetroban | 23 | Number of adverse events | ||
| Safety (Incidence and Severity of Adverse Events) | Placebo | 2 | Number of adverse events | ||
| Safety (Severity of Adverse Events) | Ifetroban | Grade 1 (mild) | 11 | Adverse Events | |
| Safety (Severity of Adverse Events) | Placebo | Grade 1 (mild) | 1 | Adverse Events | |
| Safety (Severity of Adverse Events) | Ifetroban | Grade 2 (moderate) | 8 | Adverse Events | |
| Safety (Severity of Adverse Events) | Placebo | Grade 2 (moderate) | 0 | Adverse Events | |
| Safety (Severity of Adverse Events) | Ifetroban | Greade 3 (severe) | 4 | Adverse Events | |
| Safety (Severity of Adverse Events) | Placebo | Greade 3 (severe) | 1 | Adverse Events | |
| Safety (Severity of Adverse Events) | Ifetroban | Grade 4 (life-threatening) | 0 | Adverse Events | |
| Safety (Severity of Adverse Events) | Placebo | Grade 4 (life-threatening) | 0 | Adverse Events |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ifetroban | 20 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | Ifetroban | 15 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Ifetroban | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ifetroban | 1 | 20 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 10 | 0 |
| other | Eccymosis | Blood and lymphatic system disorders | Ifetroban | 1 | 20 | 1 |
| other | Eccymosis | Blood and lymphatic system disorders | Placebo | 1 | 10 | 1 |
| other | Petechiae | Blood and lymphatic system disorders | Ifetroban | 1 | 20 | 1 |
| other | Petechiae | Blood and lymphatic system disorders | Placebo | 1 | 10 | 1 |
| other | Dental discomfort | Gastrointestinal disorders | Ifetroban | 1 | 20 | 1 |
| other | Dental discomfort | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Ifetroban | 1 | 20 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ifetroban | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | Ifetroban | 10 | 20 |
| Total, other adverse events | Placebo | 1 | 10 |
| Total, serious adverse events | Ifetroban | 2 | 20 |
| Total, serious adverse events | Placebo | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ifetroban vs Placebo: deaths from any cause | Trial comparisons |
| Ifetroban vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02802228
GET https://conductscience.org/api/trials/v1/NCT02802228/results?page=2