A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).

Not Recruiting

Trial ID: NCT00725361


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.

Stanford Investigator(s)

Lorinda Chung
Lorinda Chung

Professor of Medicine (Immunology and Rheumatology) and, by courtesy, of Dermatology


Inclusion Criteria:

   - 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:

   - Patients with pulmonary arterial hypertension, NYHA Class III or IV

   - Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary

   - 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

   - 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


drug: Ambrisentan

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305