Effects of bosentan in a homogeneous population of SSc subjects with an early or active SSc nailfold capillaroscopic patter
- Conditions
- Systemic Connective Tissue DiseaseSystemic Scleroderma100107611004704310003216
- Registration Number
- NL-OMON39115
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
1. Subjects willing and able to sign informed consent;
2. Male and female subjects > 18 years diagnosed with SSc;
3. Early or active SSc pattern, measured with nailfold capillar Microscopy (NFM);
4. Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
5. Ongoing digital ulcer disease;
6. A history of 1 or more DUs within 2 years prior to inclusion;
7. No use of bosentan in the past;
1. Parenteral Prostanoid treatment for DU < 3 months ago;
2. Chronic treatment with PDE-5 inhibitor or ERA;
3. History of bosentan use;
4. Other types of systemic or connective tissue diseases;
5. Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
6. Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
7. Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
8. Moderate to severe liver function disorder;
9. Pregnancy or breastfeeding;
10. Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
11. Hypersensitivity for bosentan or one of its components;
12. Subjects not able to follow the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in blood flow in the hands after 12 weeks of bosentan treatment compared<br /><br>to the blood flow at 0 weeks, as measured by laser Doppler imaging.</p><br>
- Secondary Outcome Measures
Name Time Method