Bosentan in Systemic Sclerosis (HOME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01395732
First received: July 6, 2011
Last updated: January 6, 2014
Last verified: January 2014

July 6, 2011
January 6, 2014
March 2011
November 2012   (final data collection date for primary outcome measure)
Mean blood flow restriction in patients [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01395732 on ClinicalTrials.gov Archive Site
Change in blood flow in the hands [ Time Frame: Baseline to 12 weeks of bosentan treatment ] [ Designated as safety issue: No ]
Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the baseline, as measured by laser Doppler imaging.
Same as current
Not Provided
Not Provided
 
Bosentan in Systemic Sclerosis
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Sclerosis
  • Digital Ulcers
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.
Experimental: 1
Intervention: Drug: Bosentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01395732
AC-052-427
No
Actelion
Actelion
Not Provided
Not Provided
Actelion
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP