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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Ambrisentan

Criteria

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 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