Systemic SclerosisPhase 4HOMENCT01395732
Bosentan in Systemic Sclerosis
A Phase 4 study testing Bosentan in people with Systemic Sclerosis and Digital Ulcers, run by Actelion at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Digital Ulcers
- What is being tested?
- Bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 10 sitesNetherlands
- Study dates
- 31 Mar 2011to 31 Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
VUmc
Amsterdam, 10811HV
UMC Groningen
Groningen, 9700RB
MCL
Leeuwarden, 8934AD
LUMC
Leiden, 2333ZA
MUMC
Maastricht, 6229HX
UMC St Radboud
Nijmegen, 6525GA
Erasmus MC
Rotterdam, 3015CE
Sint Franciscus Gasthuis
Rotterdam, 3045PM
Maasstad Ziekenhuis
Rotterdam, 3078HT
Isala Klinieken
Zwolle, 8011JW
About this study
Official title: 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.
- Conditions
- Systemic Sclerosis, Digital Ulcers
- Being tested
- Bosentan
- Medical subject headings
- Scleroderma, Systemic, digital ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood flow restriction in patients
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.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Change in blood flow in the hands
Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.
Measured: Baseline to 12 weeks of bosentan treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study start31 Mar 2011
- Primary completion30 Nov 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395732
- Sponsor's protocol ID
- AC-052-427
- Acronym
- HOME
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2011
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands
- ClinicalTrials.gov ID
- NCT01395732
- Acronym / sponsor ID
- HOME / AC-052-427
- Conditions
- Systemic Sclerosis, Digital Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2011 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bosentan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bosentan2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12. | Drug | 1 |
Primary outcome
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.
1 secondary outcome
Change in blood flow in the hands
Time frame: Baseline to 12 weeks of bosentan treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bosentan in people with Systemic Sclerosis and Digital Ulcers, run by Actelion at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood flow restriction in patients (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.