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    Summary
    EudraCT Number:2011-005303-32
    Sponsor's Protocol Code Number:AC-052-438
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-005303-32
    A.3Full title of the trial
    Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II)

    Effecten van bosentan in een homogene populatie van sclerodermie (SSc) patiënten met een ‘early’ of ‘active’ SSc patroon, gemeten met behulp van nagelriem capillair microscopie(HOME II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II)
    Het effect van bosentan in sclerodermie patienten die een bepaald nagelriem patroon vertonen (HOME II)
    A.3.2Name or abbreviated title of the trial where available
    HOME II
    HOME II
    A.4.1Sponsor's protocol code numberAC-052-438
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorActelion Pharmaceuticals Nederland bv
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportActelion Pharmaceuticals Nederland bv
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Nederland bv
    B.5.2Functional name of contact pointAffiliate Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressBeneluxlaan 2b
    B.5.3.2Town/ cityWoerden
    B.5.3.3Post code3446 GR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031348435 950
    B.5.5Fax number0031348420 904
    B.5.6E-mailgeertjan.vandaal@actelion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tracleer
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/139
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBosentan
    D.3.9.1CAS number 147536-97-8
    D.3.9.2Current sponsor codeACT-050088
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Digital Ulcera in Systemic Sclerodermia patients
    Digitale ulcera bij patienten met systemische sclerose
    E.1.1.1Medical condition in easily understood language
    Finger ulcers in patients with scleroderma
    Vingerzweren bij patienten met sclerodermie
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10053400
    E.1.2Term Endothelin increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks, measured by laser Doppler imaging, in SSc subjects with an early or active SSc pattern, measured with nailfold capillaroscopy (NFM), with ongoing digital ulcer disease and a history of DU disease in the past 2 years.
    Het evalueren van het effect van bosentan op de bloeddoorstroming in de handen, m.b.v. laser Doppler imaging, van 0 tot 12 weken, bij systemische sclerodermie patienten met aanhoudende digitale ulcera, een 'early' of 'active' SSc patroon en een geschiedenis van digitale ulcera in de 2 jaar voorafgaand aan het onderzoek.
    E.2.2Secondary objectives of the trial
    - Evaluate the effect of bosentan on the blood flow of different regions (ROI 1, ROI 2 and ROI 3, see 7.6.2) in the hands from baseline to 12 weeks, 26 weeks and 52 weeks;
    - Evaluate the effect of bosentan on the hand function, pain perception and quality of life from baseline to 12 weeks, 26 weeks and 52 weeks;
    - Evaluate the effect of bosentan on the skin involvement measured with the modified Rodnan skin score from baseline to 12 weeks, 26 weeks and 52 weeks;
    - Evaluate the effect of bosentan on the development of new digital ulcers and pitting scars from baseline to 12 weeks, 26 weeks and 52 weeks;
    - Het evalueren van het effect van bosentan op de bloeddoorstroming in verschillende regionen (ROI 1, ROI 2 en ROI 3) van de handen, van 0 tot 12, 26 en 52 weken;
    - Het evalueren van het effect van bosentan op de handfunctie, pijn perceptie en kwaliteit van leven op 12, 26 en 52
    weken in vergelijking met 0 weken;
    - Het evalueren van het effect van bosentan op de modified Rodnan Skin Score op 12, 26 en 52 weken in vergelijking
    met 0 weken;
    - Het evalueren van het effect van bosentan op het ontwikkelen van nieuwe digitale ulcera en pitting scars op 12, 26 en
    52 weken in vergelijking met 0 weken;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects willing and able to sign informed consent;
    2. Male and female subjects > 18 years diagnosed with SSc;
    3. Early or active SSc pattern, measured with nailfold capillar Microscopy (NFM);
    4. Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
    5. Ongoing digital ulcer disease;
    6. A history of 1 or more DUs within 2 years prior to inclusion;
    7. No use of bosentan in the past.
    1. Patienten die bereid en in staat zijn om het toestemmingsformulier te tekenen.
    2. Mannelijke en vrouwlijke patienten > 18 jaar gediagnosticeerd met systemiche sclerose;
    3. Early of active SSc patroon, gemeten met Nagelriem Capillair Microscopy (NCM);
    4. Vrouwen in de vruchtbare leeftijd moeten een negatieve zwangerschapstest hebben en een betrouwbare vorm van anticonceptie gebruiken;
    5. Aanhoudende digitale ulcera;
    6. Een geschiedenis van 1 of meerdere DUs in de afgelopen 2 jaar voor inclusie;
    7. Geen gebruik van bosentan in het verleden;
    E.4Principal exclusion criteria
    1. Parenteral Prostanoid treatment for DU < 3 months ago;
    2. Chronic treatment with PDE-5 inhibitor or ERA;
    3. History of bosentan use;
    4. Other types of systemic or connective tissue diseases;
    5. Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
    6. Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is < 12 months;
    7. Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
    8. Moderate to severe liver function disorder;
    9. Pregnancy or breastfeeding;
    10. Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
    11. Hypersensitivity for bosentan or one of its components;
    12. Subjects not able to follow the protocol.
    1. Behandeling met parenterale prostanoides voor DU < 3 maanden geleden;
    2. Chronische behandeling met een PDE-5 remmer of een ERA;
    3. Een geschiedenis van bosentan gebruik;
    4. Andere types systeem- of bindweefselaandoeningen;
    5. Significante perifere (macro-) vasculaire aandoening onstaan door bijv. diabetes, hyperlipidemie, ongecontroleerde systemische hypertensie, coagulopathie;
    6. Enige ernstige medische comorbiditeit (bijv. actieve maligniteit) waardoor de levensverwachting van de patient < 12 maanden is;
    7. Bekend met AST en/of ALT waarden hoger dan 3 keer Upper Limit Normal (ULN);
    8. Matige tot ernstige leverfunctie stoornis;
    9. Zwanger of borstvoeding gevend;
    10. Behandeling met Glibenclamide, Fluconazole, Cyclosporine A,Tacrolimus of een andere
    calineurineremmer;
    11. Overgevoeligheid voor bosentan of één van de ingredienten;
    12. Patienten die niet in staat zijn het protocol te volgen.
    E.5 End points
    E.5.1Primary end point(s)
    Change in blood flow in the hands after 12 weeks of bosentan treatment compared to the blood flow at 0 weeks, as
    measured by laser Doppler imaging.
    De verandering in de bloeddoorstroming in de handen na 12 weken behandeling met bosentan in vergelijking met het moment van inclusie, gemeten d.m.v. laser Doppler imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 weken
    E.5.2Secondary end point(s)
    - Change in blood flow in different regions of the hands after 12 weeks of treatment with bosentan, and after 26 and 52 weeks, compared to the baseline, measured by Laser Doppler imaging;
    - Change in the modified Rodnan Skin Score after 12 weeks of treatment with bosentan, and after 26 and 52 weeks, compared to the baseline;
    - Change in the selected components of the Scleroderma Health Assessment Questionnaire after 12 weeks of bosentan treatment, and after 26 and 52 weeks, compared to the baseline;
    - Change in the EQ 5D after 12 weeks of treatment with bosentan, and after 26 and 52 weeks, compared to the baseline;
    - The total number of new digital ulcers and pitting scars developed after 12 weeks of treatment with bosentan, and after 26 and 52 weeks, compared to the baseline.
    - Change in the DU risk score after 12 weeks of treatment with bosentan, and after 26 and 52 weeks, compared with the baseline;
    - Change in blood flow in different regions of the hands in SSc-DU patients with no history of iloprost use, after 12 weeks of treatment with bosentan, and after 26 and 52 weeks compared to the baseline, measured by Laser Doppler imaging;
    - Change on nailfold capillaries, after 12 weeks of treatment with bosentan, and after 26 and 52 weeks compared to the baseline, measured by NFM
    - De verandering in de bloeddoorstroming in de verschillende regionen van de handen na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie, gemeten d.m.v. laser Doppler imaging;
    - De verandering in de modified Rodnan Skin Score na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie;
    - De verandering in de geselecteerde componenten van de Scleroderma Health Assessment Questionnaire na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie;
    - De verandering in de EQ 5D na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie;
    - Het totale aantal nieuwe digitale ulcera en pitting scars ontwikkeld na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie.
    - De verandering in de DU risico score na 12 weken behandeling met bosentan en na 26 en 52 weken, in vergelijking met het moment van inclusie;
    - De verandering in de bloeddoorstroming in de verschillende regionen van de handen in SSc-DU patienten met geen gebruik van iloprost in het verleden, na 12 weken behandeling met bosentan en na 26 en 52 weken in vergelijking met het moment van inclusie, gemeten d.m.v. laser Doppler imaging;
    - De verandering op de nagelriem capillairen, na 12 weken behandeling met bosentan en na 26 en 52 weken in vergelijking met het moment van inclusie, gemeten met nagelriem capillair microscopy (NCM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each secundary end point will be evaluated after 12, 26 and 52 weeks.
    Elk secundaire eindpunt wordt geevalueerd na 12, 26 en 52 weken.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined by the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The medicinal product that is used in this trial is already registered and authorized to be prescribed for the indication that is being investigated in this trial. The treating physician will decide during and after the trial if the subject will keep being treated with this medicinal product.
    Het geneesmiddel dat wordt gebruikt in deze studie is reeds geregistreerd en mag worden voorgeschreven voor de indicatie die wordt onderzocht in deze studie. De behandelend arts zal tijdens en na de studieperiode beslissen of de proefpersoon zal blijven worden behandeld met dit geneesmiddel.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-03
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