The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II)

• Conditions: Digital Ulcera in Systemic Sclerodermia patients; MedDRA version: 14.1Level: PTClassification code 10053400Term: Endothelin increasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-005303-32-NL
• Lead Sponsor: Actelion Pharmaceuticals Nederland bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-26
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified