Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Launched by CUMBERLAND PHARMACEUTICALS · Feb 10, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ifetroban to see if it can help patients with diffuse cutaneous systemic sclerosis (dcSSc) or pulmonary arterial hypertension (PAH) related to systemic sclerosis. Systemic sclerosis is a serious autoimmune disease that can cause hardening and tightening of the skin and may affect internal organs. The trial is specifically looking for adults aged 18 to 79 who have been diagnosed with these conditions and meet certain health criteria.

Participants in the study will be randomly assigned to receive either ifetroban or a placebo (a dummy treatment with no active medication) to see how well it works and to check for any side effects. The trial is currently recruiting participants, and those who join can expect regular check-ups and assessments throughout the study. It’s important for potential participants to know that certain health conditions and medications may exclude them from joining the trial, so discussing this with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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.