Bosentan in Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01395732
• Date of registration: 06/07/2011
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Bosentan in Systemic Sclerosis HOME
• Scientific title: Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands
• Date of first enrolment: March 2011
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01395732
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Netherlands

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Digital Ulcers

Systemic Sclerosis

Intervention(s)

Drug: Bosentan

Primary Outcome(s)

Mean blood flow restriction in patients [Time Frame: Baseline to 12 weeks]

Secondary Outcome(s)

Change in blood flow in the hands [Time Frame: Baseline to 12 weeks of bosentan treatment]

Secondary ID(s)

AC-052-427

Source(s) of Monetary Support

Please refer to primary and secondary sponsors