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#

NCT00725361

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
Exclusion Criteria:
  1. * 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
View All Criteria
Show Less

Investigator(s)

Lorinda Chung
Lorinda Chung
Rheumatologist, Immunologist
Professor of Medicine (Immunology and Rheumatology) and, by courtesy, of Dermatology

View on ClinicalTrials.gov