Oral Ifetroban: Subjects will be treated with oral ifetroban or placebo daily for 365 days
Oral Placebo: Subjects will be treated with oral ifetroban or placebo daily for 365 days
Study summary
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Diffuse Cutaneous Criterion:
1\. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom.
SSc-PAH Criteria:
1. Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization
2. Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
3. New York Heart Association (NYHA) Class I-III Heart Failure
Exclusion Criteria:
1. Have a diagnosis of systemic sclerosis sine scleroderma;
2. Be less than 18 years of age or greater than or equal to 80 years of age;
3. Be pregnant, nursing, or planning to become pregnant;
4. Current or planned treatment with prostanoid therapy;
5. Current or planned treatment with pirfenidone;
6. Use of rituximab in the last 3 months;
7. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
8. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
9. Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted;
10. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min;
11. Have moderate or severe hepatic impairment;
12. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
13. Known hypersensitivity to gadolinium;
14. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
15. Use of aspirin \> 81 mg per day in the last two weeks;
16. Use of warfarin, heparin or other anticoagulants in the last 30 days;
17. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
18. Have a history of allergy or hypersensitivity to ifetroban;
19. Have taken investigational drugs within 30 days before study treatment administration;
20. Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments;
21. Be otherwise unsuitable for the study, in the opinion of the investigator.
Primary outcome measure(s)
Incidence of adverse events (AEs) and Serious AEs (SAEs) — 56 weeks Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
Trial sites (13)
Facility
City
Region
Status
The Universtity of Arizona Arthrtis Center
Tucson
Arizona
UCLA
Los Angeles
California
Cleveland Clinic - Florida
Weston
Florida
Johns Hopkins University
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
University of Nebraska Medical Center
Omaha
Nebraska
Hospital for Special Surgery
New York
New York
Thomas Jefferson University
Philadelphia
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Baylor Research Institute
Dallas
Texas
PGIMER
Chandigarh
Chandigarh
KDH - Kokilaben Dhirubhai Ambani Hospital
Mumbai
Maharashtra
B. J. Government Medical College
Pune
Maharashtra
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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