A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
Trial ID or NCT#
This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.
A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.
- - Diagnosis of limited or diffuse systemic sclerosis (SSc) according to American College of Rheumatology or LeRoy criteria
- - Age greater than 18 years of age
- - At least one digital ulcer located on the volar or lateral surface at or distal to the proximal interphalangeal joints
- - At least one new DU that developed within 12 weeks prior to screening
- - Vasodilator therapies, including calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, nitroglycerin, and angiotensin receptor blockers, are permitted as long as the doses are stable for 2 weeks prior to screening and throughout the study
- - Treatment with omeprazole or other proton pump inhibitors must be stable for 2 weeks prior to screening and throughout the study
- - Patients with pulmonary arterial hypertension, NYHA Class III or IV
- - Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary failure
- - Concurrent malignancy except non-melanoma skin cancers
- - Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of screening
- - Patients receiving phosphodiesterase-5 inhibitors, endothelin receptor antagonists, or prostanoids within 4 weeks of screening
- - Patients receiving cyclosporine within 6 weeks of screening
- - Patients who have participated in any investigational study within 30 days of screening
- - Pregnant or nursing women
- - Patients with a history of drug or alcohol abuse within 6 months of screening
- - History of hepatitis B, hepatitis C, or HIV infection
- - Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
- - Inability to comply with study and follow-up procedures
- - Transaminase elevation > 3X the upper limit of normal at screening
- - Hemoglobin less than 8.5 g/dL
- - Platelet count less than 100 X 109/L
- - White blood cell count less than 3.0 X 109/L
- - Serum creatinine less than 2.0 mg/dL
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