Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT01395732
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects \> 18 years diagnosed with SSc;
* Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to the healthy volunteers;
* Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
* A history of 1 or more DUs within 2 years prior to inclusion;
* No use of bosentan in the past;
* Subjects willing and able to sign informed consent.
Exclusion Criteria:
* Parenteral prostanoid treatment for DU \< 3 months ago;
* Chronic treatment with PDE-5 inhibitor or ERA;
* History of bosentan use
* Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
* Other types of system- or connective tissue diseases;
* Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
* Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is \< 12 months;
* Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
* Moderate to severe liver function disorder;
* Pregnancy or breastfeeding;
* Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
* Hypersensitivity for bosentan or one of its components;
* Subjects not able to follow the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01395732
Study Brief:
Protocol Section:
NCT01395732