Portal HypertensionPhase 2NCT02802228
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
A Phase 2 study testing Ifetroban in people with Portal Hypertension and Liver Cirrhosis, run by Cumberland Pharmaceuticals at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Hypertension, Liver Cirrhosis
- What is being tested?
- Ifetroban
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Mar 2017to 17 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis
- baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg
- stable liver function enzymes
Who cannot join
- portal or splenic vein thrombosis
- Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt
- variceal bleed in last 2 months
- hemodialysis
- Child-Pugh Score >= 12
- Model for End-stage Liver Disease- Sodium score (MELD-Na) >= 20
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
Indiana University
Indianapolis, Indiana, 46202
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23114
Tampa General Medical Group
Tampa, Florida, 33606
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Safety and Efficacy of Ifetroban for the Treatment of Portal Hypertension in Cirrhotic Patients
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
- Conditions
- Portal Hypertension, Liver Cirrhosis
- Being tested
- Ifetroban, Placebo
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IfetrobanDrug
thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
PlaceboDrug
matched placebo delivered as infusion and oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Ifetroban | Experimental | 90 day course of oral ifetroban following intravenous loading dose Receives: Drug: Ifetroban |
| Placebo | Placebo comparator | 90 day course of placebo following intravenous dose of 5% dextrose in water (D5W) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through 90 days treatment and 7 days follow-up
Secondary outcomes (5)
Change in Hepatic Venous Pressure Gradient (HVPG)
The HVPG will be measured through Day 90 and will be compared to baseline
Measured: Baseline and 90 days
Change in Aspartate Aminotransferase (AST)
AST values through Day 90 will be compared to baseline
Measured: Baseline and 90 days
Alanine Aminotransferase (ALT)
ALT values through Day 90 will be compared to baseline
Measured: Baseline and 90 days
Aspartate Aminotransferase/Platelet Ratio (APRI)
The Aspartate Aminotransferase/Platelet Ratio through Day 90 will be compared to baseline
Measured: 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
Measured: Through Day 97
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start6 Mar 2017
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Rockey, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802228
- Sponsor's protocol ID
- CPI-IFE-005
- Status last verified
- Jan 2021
- First submitted
- 9 Jun 2016
- Last updated
- 19 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Safety and Efficacy of Ifetroban for the Treatment of Portal Hypertension in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02802228
- Acronym / sponsor ID
- CPI-IFE-005
- Conditions
- Portal Hypertension, Liver Cirrhosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 19 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ifetroban | Experimental | Drug: Ifetroban90 day course of oral ifetroban following intravenous loading dose |
| Placebo | Placebo comparator | Drug: Placebo90 day course of placebo following intravenous dose of 5% dextrose in water (D5W) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- liver cirrhosis
- baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg
- stable liver function enzymes
Key exclusion criteria (13 listed)
- portal or splenic vein thrombosis
- Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt
- variceal bleed in last 2 months
- hemodialysis
- Child-Pugh Score >= 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifetrobanthromboxane prostanoid receptor antagonist delivered as infusion and oral capsule | Drug | Ifetroban |
| Placebomatched placebo delivered as infusion and oral capsule | Drug | Placebo |
Primary outcome
Safety (Incidence and Severity of Adverse Events)
Time frame: 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.
Safety (Severity of Adverse Events)
Time frame: 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.
5 secondary outcomes
Change in Hepatic Venous Pressure Gradient (HVPG)
Time frame: Baseline and 90 days
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline and 90 days
Alanine Aminotransferase (ALT)
Time frame: Baseline and 90 days
Aspartate Aminotransferase/Platelet Ratio (APRI)
Time frame: Baseline and 90 days
Variceal Bleeds (Occurrence of Variceal Bleeds)
Time frame: Through Day 97
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Rockey, MD principal investigator
Medical University of South Carolina
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifetroban in people with Portal Hypertension and Liver Cirrhosis, run by Cumberland Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Incidence and Severity of Adverse Events) (time frame: Through 97 days (90 days treatment and 7 days follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.