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    The EU Clinical Trials Register currently displays   42882   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-005117-18
    Sponsor's Protocol Code Number:640
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-04
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-005117-18
    A.3Full title of the trial
    Safety and efficacy study of bosentan in progressive pulmonary sarcoidosis
    A.3.2Name or abbreviated title of the trial where available
    BOPSAC
    A.4.1Sponsor's protocol code number640
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Vienna, Department of Clinical Pharmacology
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBosentan
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive pulmonary sarcoidosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10037430
    E.1.2Term Pulmonary sarcoidosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate treatment efficacy of bosentan as add-on therapy in progressive pulmonary sarcoidosis in comparison to placebo, as measured by a composite clinical score based on pulmonary function test, cardiopulmonary exercise testing, HRCT and dyspnoea level.
    E.2.2Secondary objectives of the trial
    • To assess safety and tolerability of bosentan in patients with pulmonary sarcoidosis.
    • To asses effect of bosentan treatment on quality of live
    • To assess differences in treatment efficacy in patients with and without pulmonary hypertension secondary to pulmonary sarcoidosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent prior to any study-mandated procedure.
    • Male and female patients aged > 18 and < 70 yrs.
    • Histologically proven sarcoidosis diagnosed at least one year before screening.
    • Diagnosis of sarcoidosis and with evidence of pulmonary parenchymal disease on chest X-ray or CT (radiological stage II, III) with or without pulmonary hypertension. Subjects with concurrent extrapulmonary sarcoidosis are encouraged to be enrolled.
    • Progressive disease, defined as follows:
    o Deterioration in the 3-12 month period prior to screening in at least two of the
    following criteria:
    - increase in clinical symptoms (cough, shortness of breath, chest pain,
    fatigue or hemoptysis).
    - lung function: decrease of 10 % in TLC, FVC or DLCO.
    - worsening of radiographic opacities.
    o Have been receiving pre-study treatment with prednisolone (or equivalent
    dose of corticosteroid) as a single agent (≥ 10 mg/day) or other
    immunosuppressants (methotrexate, azathioprine, cyclophosphamide, TNF
    inhibitors, etc.) within the 3-month period immediately prior to screening.
    Patients must be on a stable dose of these medicatins for > 4 weeks before
    starting the study medication.
    • AST and ALT values within three times upper limit of normal.
    • Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
    • Negative pregnancy test in female patients.
    • Adequate contraception in female patients of childbearing age.
    E.4Principal exclusion criteria
    • Known hypersensitivity to any excipients of the drug formulation or to bosentan.
    • Treatment with another investigational drug within 3 months prior to screening.
    • Pulmonary sarcoidosis
    o without disease progression as defined above
    o with radiological stage I
    o with radiological stage IV (pulmonary fibrosis with evidence of honey-combing,
    hilar retraction, bullae and cysts)
    • Other cause of pulmonary disease:
    o Active tuberculosis (or positive Quantiferon test), fungi infection, lymphoma.
    o Chronic obstructive pulmonary disease, asthma, interstitial lung disease other
    than sarcoid-related
    • Anamnesis of beryllium or asbestos exposition
    • Previous smoking (> 10 PY), or active smoker
    • Previous administration of bosentan
    • Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
    • Positive results from the HIV serology at screening.
    • Malignancy requiring chemotherapy or radiation
    • Uncontrolled other disease like
    o Chronic heart failure (NYHA III, IV)
    o Diabetes mellitus (blood glucose 2x per day > 250 mg/dl , HbA1c > 10 %)
    o Arterial hypertension (SBP > 180 mmHg)
    • Concomitant treatment with cyclosporine A
    • Concomitant treatment with tacrolimus or sirolimus
    • Concomitant treatment with glibenclamid
    • Are pregnant, nursing, or planning pregnancy during the trial or within six month period thereafter
    • Have a known substance dependency (drug or alcohol within 3 years of screening)
    • Presumed non-compliance.
    • Legal incapacity or limited legal capacity at screening.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment efficacy of bosentan compared to placebo is based on disease progression from screening to EOS investigation assessed by a composite clinical score, including six parameters:
    • Pulmonary function test (FVC and DLCO)
    • Blood gas analysis (AaDO2)
    • HRCT (Oberstein score)
    • Cardiopulmonary exercise testing (VO2max)
    • Dyspnoea (ATS dyspnea scale)
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned2
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state32
    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)
    Study medication will be stopped after the six month treatment period in all patients. Every randomization block of four patients finished treatment period will be immediately unblinded. In case of active treatment assignment (bosentan group) and based on individual treatment benefit and eventual positive study results, a possible extension of bosentan treatment will be negotiated with local health care providers and health insurance companies.
    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 Decision2008-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-03-08
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