Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2006-001183-24
    Sponsor's Protocol Code Number:AC-052-321
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-05
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-001183-24
    A.3Full title of the trial
    Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study
    A.3.2Name or abbreviated title of the trial where available
    BUILD 3
    A.4.1Sponsor's protocol code numberAC-052-321
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberAC-052-321
    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 SponsorActelion Pharmaceuticals LTD
    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 support
    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. name TRACLEER
    D. of the Marketing Authorisation holderACTELION
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboFilm-coated 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
    Patients with Idiopathic pulmonary fibrosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level PT
    E.1.2Classification code 10037383
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demostrate that bosentan delays desease worsening or death in patients with idiopathic pulmonary fibrosis IPF
    E.2.2Secondary objectives of the trial
    To assess the effects of bosentan on quality of live, dyspnea and pulmonaruyy function tests PFT in this patients population. To assess the safety and tolerability of bosentan in this patients population
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Signed informed consent. Male or female patients aged 18 years or older females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception . Proven diagnosis of IPF according to ATS/ERS statement, of 3 years, with surgical lung biopsy SLB .
    E.4Principal exclusion criteria
    Interstitial lung disease due to conditions other than IPF. Presence of extensive honeycomb HC on Baseline high-resolution computed tomography HRCT scan. The patient is not allowed in BUILD 3 if HC involves more than 5 of the parenchyma in 3 or more of the 6 zones i.e., right and left lung, viewed at the levels of tracheal carina, inferior pulmonary veins, and 1 cm above the dome of the diaphragm , whether the involvement is unilateral or bilateral. Severe concomitant illness limiting life expectancy 1 year . Severe restrictive lung disease forced vital capacity FVC 50 predicted, or FVC 1.2 liter. Diffusing capacity of the lung for carbon monoxide DLCO 30 predicted. Residual volume 120 predicted. Obstructive lung disease forced expiratory volume in 1 second FEV1 /FVC 0.65. Documented sustained improvement of patient s IPF condition up to 12 months prior to randomization with or without IPF-specific therapy. Recent pulmonary or upper respiratory tract infection up to 4 weeks prior to randomization . Acute or chronic impairment other than dyspnea limiting the ability to comply with study requirements e.g., pulmonary function tests . Chronic heart failure with NYHA class III/IV or known left ventricular ejection fraction 25 . ALT/SGPT and/or AST/SGOT 1.5 times the upper limit of the normal ranges ULN . Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C. Serum creatinine 8805; 2.5 mg/dl 221 mmol/l or chronic dialysis. Hemoglobin concentration 75 the lower limit of the normal ranges. Systolic blood pressure 85 mmHg. Pregnancy or breast-feeding. Current drug or alcohol dependence. Chronic treatment with the following drugs prescribed for IPF within 4 weeks of randomization -Oral corticosteroids 20 mg/day of prednisone or equivalent , -Immunosuppressive or cytotoxic drugs, -Antifibrotic drugs including pirfenidone, D-penicillamine, colchicine, TNFa blocker, imatinib, interferon g, cyclophosphamide, azathioprine, -Chronic use of N-acetylcysteine prescribed for IPF . Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease. Treatment with glibenclamide glyburide and calcineurin inhibitors cyclosporine A, tacrolimus up to 1 week prior to randomization. Treatment with an endothelin receptor antagonist up to 3 months prior to randomization. Participation in the BUILD 1 trial. Treatment with another investigational drug up to 3 months prior to randomization or planned treatment. Known hypersensitivity to bosentan or any of the excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint Time to occurrence of disease worsening or death up to EOS. Disease worsening is defined as worsening of PFTs or acute exacerbation of IPF.1 Worsening of PFTs confirmed by two tests at least 4 weeks apart is defined as the occurrence of both Decrease from baseline 10 in FVC absolute values, i.e., liters and Decrease from baseline 15 in DLCO absolute values, i.e., ml mmHg 1 min-1 A patient unable to perform PFTs at a planned visit due to worsening of IPF will be considered as having a worsening of PFTs if the latter are not invalidated by a test at a follow-up visit.2 Acute exacerbation of IPF is defined as An unexplained rapid deterioration of patient s condition within 4 weeks with an increasing shortness of breath requiring hospitalization and oxygen supplementation 8805; 5 liters/min to maintain a resting SaO2 90 or PaO2 55 mmHg sea level or 50 mmHg high altitude .A documented acute exacerbation of IPF will be considered to be an event, irrespective of the results of any follow-up PFTs or fatal outcome.Patients who are transplanted without a prior documented disease worsening , or who withdraw their consent, or those lost to follow-up before the EOS will be censored at the patient s EOS visit date.Patients starting forbidden IPF medications without prior documented disease worsening as defined above will not be considered as having reached an event.The risk of an event in one group relative to the other is not expected to change with time. The risk of an event in the placebo group is expected to be 25 / year. The treatment effect to be detected is a 40 relative risk reduction in event rate and corresponds to a Hazard Ratio for bosentan/placebo of 0.565, i.e., the risk is expected to be 15 / year in the bosentan group. Safety end poins Treatment-emergent adverse events up to 24 hours after EOT. Adverse events leading to premature discontinuation of study drug. Treatment-emergent liver-related laboratory abnormalities up to 24 hours after EOT including aminotransferases 3 ULN . Treatment-emergent serious adverse events up to 24 hours after EOT.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E. trial design description
    Event driven, group sequential
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-05. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 265
    F.4.2.2In the whole clinical trial 390
    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 Decision2006-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-29
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice