Effects of bosentan in a HOMogenEous population of SSc subjects with a predefined restriction of blood flow in the hands (HOME) - HOME

Phase 1

Active, not recruiting

• Conditions: Digital Ulcera in Systemic Sclerodermia patients; MedDRA version: 12.1Level: LLTClassification code 10053400Term: Endothelin increased

• Registration Number: EUCTR2010-023908-27-NL
• Lead Sponsor: Actelion Pharmaceuticals Nederland bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-24
• Study Completion: 2012-11-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male and female subjects > 18 years diagnosed with SSc;
2. Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to historical healthy controls;
3. Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
4. A history of 1 or more DUs within 2 years prior to inclusion;
5. No use of bosentan in the past;
6. Subjects willing and able to sign informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
5. Other types of system- or connective tissue diseases;
6. Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
7. Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
8. Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
9. Moderate to severe liver function disorder;
10. Pregnancy or breastfeeding;
11. Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
12. Hypersensitivity for bosentan or one of its components;
13. Subjects not able to follow the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified