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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ifetroban | Experimental | 90 day course of oral ifetroban following intravenous loading dose |
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| Placebo | Placebo Comparator | 90 day course of placebo following intravenous dose of 5% dextrose in water (D5W) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ifetroban | Drug | thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence and Severity of Adverse Events) | Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group. | Through 97 days (90 days treatment and 7 days follow-up) |
| Safety (Severity of Adverse Events) | 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. | Through 90 days treatment and 7 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hepatic Venous Pressure Gradient (HVPG) | The HVPG will be measured through Day 90 and will be compared to baseline | Baseline and 90 days |
| Change in Aspartate Aminotransferase (AST) | AST values through Day 90 will be compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Rockey, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Medical Group | Tampa | Florida | 33606 | United States | ||
| Indiana University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ifetroban | 90 day course of oral ifetroban following intravenous loading dose Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2017 |
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| Placebo | Drug | matched placebo delivered as infusion and oral capsule |
|
| Baseline and 90 days |
| Alanine Aminotransferase (ALT) | ALT values through Day 90 will be compared to baseline | Baseline and 90 days |
| Aspartate Aminotransferase/Platelet Ratio (APRI) | The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline | Baseline and 90 days |
| Variceal Bleeds (Occurrence of Variceal Bleeds) | The number of variceal bleeds during the treatment and follow-up periods will be evaluated | Through Day 97 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23114 | United States |
90 day course of placebo following intravenous dose of 5% dextrose in water (D5W)
Placebo: matched placebo delivered as infusion and oral capsule
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ifetroban | 90 day course of oral ifetroban following intravenous loading dose Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule |
| BG001 | Placebo | 90 day course of placebo following intravenous dose of D5W Placebo: matched placebo delivered as infusion and oral capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary Cirrhosis Etiology | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety (Incidence and Severity of Adverse Events) | Incidence is measured as the total number of adverse events reported during the treatment and follow-up period for each treatment group. | Posted | Number | Number of adverse events | Through 97 days (90 days treatment and 7 days follow-up) |
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| Primary | Safety (Severity of Adverse Events) | 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. | Posted | Count of Units | Adverse Events | Through 90 days treatment and 7 days follow-up | Adverse Events | Adverse Events |
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| Secondary | Change in Hepatic Venous Pressure Gradient (HVPG) | The HVPG will be measured through Day 90 and will be compared to baseline | Posted | Mean | Standard Deviation | mmHg | Baseline and 90 days |
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| Secondary | Change in Aspartate Aminotransferase (AST) | AST values through Day 90 will be compared to baseline | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | Posted | Mean | Standard Deviation | U/L | Baseline and 90 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) | ALT values through Day 90 will be compared to baseline | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | Posted | Mean | Standard Deviation | U/L | Baseline and 90 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase/Platelet Ratio (APRI) | The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline | The analysis was performed on all subjects that had data available for the Baseline to Day 90 comparison. | Posted | Mean | Standard Deviation | ratio | Baseline and 90 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Variceal Bleeds (Occurrence of Variceal Bleeds) | The number of variceal bleeds during the treatment and follow-up periods will be evaluated | Posted | Number | events of variceal bleeding | Through Day 97 |
|
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90 days of investigational treatment and 7 days of follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ifetroban | 90 day course of oral ifetroban following intravenous loading dose Ifetroban: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule | 0 | 20 | 2 | 20 | 10 | 20 |
| EG001 | Placebo | 90 day course of placebo following intravenous dose of D5W Placebo: matched placebo delivered as infusion and oral capsule | 0 | 10 | 1 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
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| oesophageal varices haemorrhage | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Eccymosis | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Petechiae | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Dental discomfort | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Subacute cutaneous lupus erythematosus | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
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| Thromboelastogram | Investigations | MedDRA (17.1) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Vertigo positional | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Non-cardiac chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry Fox, DVM | Cumberland Pharmaceuticals | 615-255-0068 | jfox@cumberlandpharma.com |
| Jan 29, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078904 | ifetroban |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hepatitis C only |
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| Hepatitis B and C |
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| Non-alcoholic Steatohepatitis |
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| Alcoholic |
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| Auto-immune |
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| Cryptogenic |
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| Participants |
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| Adverse Events |
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