Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.
This is a multicenter, prospective, randomized, placebo-controlled, phase II study to determine the safety and efficacy of oral ifetroban compared to placebo in subjects with IPF. Patients who meet the inclusion criteria and none of the exclusion criteria will receive oral ifetroban or placebo once daily for 12 months. Subjects will be randomly assigned to one of two oral treatment groups: ifetroban or placebo and block randomized by background therapy. All subjects who receive treatment will be assessed for safety. All subjects with at least one efficacy assessment post-baseline will be evaluated for efficacy. Blood and urine will be collected for standard and novel PPF biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Once daily oral ifetroban
Matching oral placebo
Biosolutions Clinical Research
La Mesa, California, United States
Change from baseline in Forced Vital Capacity (FVC) in mL
To demonstrate a reduction in lung function decline for ifetroban compared to placebo over 52 weeks.
Time frame: Baseline through 12 months
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death over 52 weeks
Time frame: Baseline through 12 months
Time to first acute IPF exacerbation or death
Time to first acute IPF exacerbation or death over 52 weeks
Time frame: Baseline through 12 months
Proportion of patients with acute exacerbations of lung fibrosis
Proportion of patients with acute exacerbations of lung fibrosis, defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as deemed by the investigator, for the following: * Acute worsening or development of dyspnea (\<1-month duration). * Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern of lung fibrosis. * Respiratory deterioration not fully explained by cardiac failure or fluid overload.
Time frame: Baseline through 12 months
Time to hospitalization for respiratory cause or death
Time to hospitalization for respiratory cause or death over 52 weeks
Time frame: Baseline through 12 months
Change from baseline in quality of life (SOBQ)
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University of California San Francisco
San Francisco, California, United States
RECRUITINGUConn Health
Farmington, Connecticut, United States
RECRUITINGMayo Clinic Jacksonville
Jacksonville, Florida, United States
RECRUITINGMiami VA Health System
Miami, Florida, United States
RECRUITINGNorthwestern Medicine
Chicago, Illinois, United States
RECRUITINGIndiana University Health
Indianapolis, Indiana, United States
RECRUITINGUniversity of Kansas
Kansas City, Kansas, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGBeaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
RECRUITING...and 10 more locations
The University of California, San Diego (UCSD) Medical Center Shortness of Breath Questionnaire (SOBQ) assesses the impact of a subject's lung disease on their quality of life. The assessment scale asks the patient to rate their breathlessness while performing a specific task using a numeric scale from 0 - 5, with 0 being "none at all" and 5 being "maximal or unable to do because of breathlessness". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the dyspnea domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "not at all" or "extremely poor" and 4 being "extremely" or "excellent". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the Cough domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "never" or "none at all" or "none" or "Not at all" or very little time" and 4 being "extremely" or "all of the time" or "A lot" or "extremely long time". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the Fatigue domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "Made my quality of life extremely poor" or "Extremely poor" and 4 being "No negative effect" or "Excellent". Lower scores = high impact; higher scores = low impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Time frame: Baseline through 12 months
Time to death
Time to death over 52 weeks
Time frame: Baseline through 12 months
Incidence of Treatment Emergent Adverse Events (safety & tolerability)
Percentage of subjects with one or more treatment emergent adverse event
Time frame: Baseline through 12 months