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Bosentan in Systemic Sclerosis (HOME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395732
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):

Brief Summary:
The effect of bosentan on digital ulcers (DU) was studied in two randomized placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the heterogeneous study population. More importantly, there were no endpoints that assessed changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to effectively demonstrate blood flow restrictions in the hands of patients with Systemic Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser Doppler imaging and the extent of DU disease has not been studied. The current study will attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2 years and a clinically relevant reduction of blood flow in the hands, will be assessed.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Digital Ulcers Drug: Bosentan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands
Study Start Date : March 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Bosentan

Arm Intervention/treatment
Experimental: 1 Drug: Bosentan
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.

Primary Outcome Measures :
  1. Mean blood flow restriction in patients [ Time Frame: Baseline to 12 weeks ]
    Relationship between blood flow in the hands, as measured by laser Doppler imaging, and extent of Digital Ulcer disease assessed by the mean blood flow restriction in four distinct groups of patients: patients without current Digital Ulcers (pitting scars allowed), patients with new Digital Ulcers (< 3 months), patients with persistent Digital Ulcers (> 3 months) and patients with significant tip-necrosis.

Secondary Outcome Measures :
  1. Change in blood flow in the hands [ Time Frame: Baseline to 12 weeks of bosentan treatment ]
    Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395732

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Amsterdam, Netherlands, 10811HV
UMC Groningen
Groningen, Netherlands, 9700RB
Leeuwarden, Netherlands, 8934AD
Leiden, Netherlands, 2333ZA
Maastricht, Netherlands, 6229HX
UMC St Radboud
Nijmegen, Netherlands, 6525GA
Erasmus MC
Rotterdam, Netherlands, 3015CE
Sint Franciscus Gasthuis
Rotterdam, Netherlands, 3045PM
Maasstad Ziekenhuis
Rotterdam, Netherlands, 3078HT
Isala Klinieken
Zwolle, Netherlands, 8011JW
Sponsors and Collaborators

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Responsible Party: Actelion Identifier: NCT01395732    
Other Study ID Numbers: AC-052-427
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action