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Prostaglandin Receptor Antagonist

Ifetroban Sodium for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Led By Todd Rice, MD, MSc

Research Sponsored by Cumberland Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP

Meeting specific requirements for receiving antifibrotic agents pirfenidone or nintedanib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 12 months

Awards & highlights

Study Summary

This trial will test if a drug called Ifetroban can help treat lung fibrosis caused by various factors like bleomycin, genetics, or radiation. The study will look at how safe and effective

Who is the study for?

This trial is for men and women over 40 with Idiopathic Pulmonary Fibrosis (IPF) who meet specific diagnostic criteria. They should have a certain lung function level, may be on stable doses of antifibrotic agents or treatment for pulmonary hypertension, but not have significant emphysema or recent major health events like surgery or heart disease.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of oral Ifetroban in treating IPF compared to a placebo. Participants will either receive Ifetroban Sodium or an inactive substance without knowing which one they are taking to measure true effects.See study design

What are the potential side effects?

While the side effects of Ifetroban in this context aren't detailed here, common risks might include digestive issues, potential liver or kidney function changes, bleeding risks due to its effect on blood cells and vessels, as well as possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent chest scan or past lung biopsy shows a pattern of lung scarring.

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I am eligible for treatment with pirfenidone or nintedanib.

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I am 40 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Forced Vital Capacity (FVC) in mL

Secondary outcome measures

Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score

Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score

Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score

+7 more

Side effects data

From 2015 Phase 2 trial • 55 Patients • NCT01436500

12%

Dyspnoea

10%

abdominal pain

hypotension

chronic hepatic failure

atrial fibrillation

nausea

anaemia

peritoneal haemorrhage

dyspnoea

respiratory failure

Atrial fibrillation

Renal failure chronic

deep vein thrombosis

worsening renal function

device failure

liver disorder

bacteraemia

complications of transplanted liver

post procedural haematoma

peritonitis bacterial

renal failure

hypoxia

catheter site haemorrhage

haematemesis

haematochezia

shock haemorrhagic

upper gastrointestinal haemorrhage

hyperkalaemia

Bradycardia

hepatorenal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Ifetroban

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ifetroban SodiumExperimental Treatment1 Intervention

Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months

Group II: PlaceboPlacebo Group1 Intervention

Drug: Placebo Matching placebo, oral capsule, once daily for 12 months

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor

62 Previous Clinical Trials

9,335 Total Patients Enrolled

Todd Rice, MD, MScPrincipal InvestigatorCumberland Pharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals who are 60 years of age and older participate in this research investigation?

"Patients between the ages of 40 and 80 are sought for inclusion in this particular investigation. Interestingly, there are a substantial number of trials available specifically for individuals younger than 18 years old (63 trials) as well as those older than 65 (361 trials)."

Answered by AI

What are the potential risks associated with Ifetroban Sodium when used by patients?

"Our team at Power has assessed the safety of Ifetroban Sodium to be a 2 on our scale due to being in Phase 2, where there is existing data supporting its safety but none backing its efficacy."

Answered by AI

Which specific criteria determine the inclusion of individuals into this research study?

"Patients aged between 40 and 80 with a diagnosis of idiopathic pulmonary fibrosis are eligible to participate in this trial, which aims to enroll approximately 128 individuals."

Answered by AI

How large is the participant pool for this clinical trial in its entirety?

"Affirmative. The details on clinicaltrials.gov indicate that patient recruitment is ongoing for this research project. This trial was initially posted on January 31, 2024 and last revised on February 1, 2024. It seeks to enroll a total of 128 participants from a single site."

Answered by AI

Are participants currently being actively enrolled in this research study?

"Indeed, as per the information available on clinicaltrials.gov, this current medical trial is actively pursuing potential participants. The trial was introduced for recruitment on January 31st, 2024 and underwent its most recent update on February 1st, 2024. A total of 128 individuals are sought after at a singular research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

2024. "Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571059.

All > Pulmonary Fibrosis > Idiopathic Pulmonary Fibrosis