- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01395732
Bosentan in Systemic Sclerosis (HOME)
January 6, 2014 updated by: Actelion
Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amsterdam, Netherlands, 10811HV
- VUMC
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Groningen, Netherlands, 9700RB
- UMC Groningen
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Leeuwarden, Netherlands, 8934AD
- MCL
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Leiden, Netherlands, 2333ZA
- LUMC
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Maastricht, Netherlands, 6229HX
- MUMC
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Nijmegen, Netherlands, 6525GA
- UMC St Radboud
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Rotterdam, Netherlands, 3015CE
- Erasmus MC
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Rotterdam, Netherlands, 3045PM
- Sint Franciscus Gasthuis
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Rotterdam, Netherlands, 3078HT
- Maasstad Ziekenhuis
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Zwolle, Netherlands, 8011JW
- Isala Klinieken
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 12 weeks of bosentan treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
July 6, 2011
First Submitted That Met QC Criteria
July 14, 2011
First Posted (Estimate)
July 18, 2011
Study Record Updates
Last Update Posted (Estimate)
January 7, 2014
Last Update Submitted That Met QC Criteria
January 6, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-052-427
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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