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    Summary
    EudraCT Number:2006-000138-11
    Sponsor's Protocol Code Number:PIPF-006
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-04-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-000138-11
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
    A.4.1Sponsor's protocol code numberPIPF-006
    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 SponsorInterMune, Inc.
    B.1.3.4CountryUnited States
    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.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 Information not present in EudraCT
    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/3/04/241
    D.3 Description of the IMP
    D.3.1Product namePirfenidone
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNPirfenidone
    D.3.9.1CAS number 5317-13-8
    D.3.9.2Current sponsor codePIR, S-7701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    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 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 placeboCapsule, hard
    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
    Idiopathic Pulmonary Fibrosis (IPF)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - to assess the efficacy of treatment with pirfenidone 2403 mg/d compared with placebo in patients with idiopathic pulmonary fibrosis
    - to assess the safety of treatment with pirfenidone 2403 mg/d compared with placebo in patients with idiopathic pulmonary fibrosis
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Clinical symptoms consistent with IPF, including the insidious onset of
    otherwise unexplained dyspnea on exertion, of more or equal to 3 months duration
    2. Diagnosis of IPF, defined as first instance in which a patient was informed of
    having IPF, within 48 months of randomization
    3. Age 40 through 80 years, inclusive
    4. High-resolution computed tomographic (HRCT) scan showing a pattern of
    disease consistent with a confident (definite) radiographic diagnosis of usual
    interstitial pneumonia (UIP)/IPF. For patients with surgical lung biopsy showing
    definite or probable UIP, the HRCT criterion of probable (UIP)/IPF is sufficient.
    5. For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung
    biopsy showing definite or probable UIP within 48 months of randomization. In
    addition, there are no features supporting an alternative diagnosis on
    transbronchial biopsy or bronchoalveolar lavage (BAL), if performed .
    6. For patients aged more than or equal to 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months of randomization.
    a. Open or VATS lung biopsy showing definite or probable UIP.
    b. Transbronchial biopsy showing no features to support an alternative
    diagnosis. These alternative diagnoses include but are not limited to
    granulomatous disease, sarcoidosis, and hypersensitivity pneumonitis.
    c. BAL showing no features to support an alternative diagnosis
    7. FVC more or equal to 50% of predicted value
    8. Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon
    monoxide transfer capacity (DLCO /TLCO) more or equal to 35% of predicted value
    9. Either FVC or Hb-corrected DLCO /TLCO less or equal to 90% of predicted value
    10. No evidence of improvement in measures of IPF disease severity over the
    preceding year
    11. Distance walked more or equal to 150 meters (492 feet) with O2 saturation more or equal to 83% on less or equal to 6 L/min of O2 during the 6-Minute Walk Test (6MWT) oxygen titration procedure performed during screening
    12. Able to understand and sign a written informed consent form
    13. Able to understand the importance of adherence to study treatment and the study protocol, including the concomitant medication restrictions throughout the Study Period
    E.4Principal exclusion criteria
    1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
    2. Premature withdrawal from a randomized IPF clinical trial in the previous 2 years for any reason other than Sponsor decision or current participation in a clinical drug trial
    3. Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 after administration of bronchodilator
    4. Bronchodilator Response defined by an absolute increase in FEV1 or FVC of >12% predicted or 200 mL after bronchodilator use
    5. The change in FVC between the Screen Visit and Day 1 (Baseline) cannot vary by more than 10% absolute difference and the Bronchodilator Response, Baseline FVC and FEV1/FVC ratio must all continue to meet the inclusion and exclusion criteria
    6. Residual volume (RV) >120% of predicted (before administration of bronchodilator)
    7. History of clinically significant environmental exposure known to cause PF (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
    8. Known explanation for interstitial lung disease, including but not limited to
    radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis and cancer
    9. Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
    10. Clinical evidence of active infection, including but not limited to bronchitis,
    pneumonia, sinusitis, urinary tract infection, or cellulitis
    11. On a lung transplantation waiting list at time of randomization
    12. Unable to undergo pulmonary function testing
    13. Any history of malignancy likely to result in death or significant disability or
    likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
    14. Any condition other than IPF which, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years
    15. History of advanced cirrhosis or clinically significant liver disease
    16. History of unstable or deteriorating cardiac or pulmonary disease (other than
    IPF) within the previous 6 months, including but not limited to the following:
    a. Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty
    b. Congestive heart failure requiring hospitalization
    c. Uncontrolled arrhythmias
    d. Asthma or chronic bronchitis requiring hospitalization in the last 6 months
    17. Any condition, which, in the opinion of the investigator, might be significantly
    exacerbated by the known side effects associated with the administration of
    pirfenidone
    18. Poorly controlled diabetes (defined by glycosolated hemoglobin [HbA1C] >10)
    19. Pregnancy or lactation. Women of childbearing capacity are required to have a
    negative serum pregnancy test before treatment and must agree to practice
    abstinence or prevent pregnancy by two methods of birth control from the date
    of screening through the duration of the study (i.e. oral contraception and a spermicide, diaphragm and a spermicide, etc.).
    20. History of alcohol or substance abuse in the past 2 years
    21. History of any condition or habit associated with altered consciousness and a
    risk of aspiration in the past 2 years
    22. Family or personal history of long QT-wave syndrome
    23. Any of the following liver function test criteria above specified limits: total bilirubin >2.5 x upper limit of normal (ULN); aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >2.5 x ULN; alkaline phosphatase >2.5 x ULN
    24. Screening or Baseline ECG with a QTcB interval >500 msec
    25. Prior use of pirfenidone or known hypersensitivity to any of the components of
    study treatment
    26. Investigational therapy (i.e., agents that are not approved by local regulatory
    agencies) for any indication within 28 days prior to screening
    27. The following therapies are excluded within 28 days prior to screening:
    a. Any cytotoxic/immunosuppressive agent including but not limited to
    corticosteroids, azathioprine, cyclophosphamide, methotrexate, and cyclosporine
    b. Any cytokine modulators (including but not limited to etanercept, infliximab)
    c. Any other therapy that has been investigated or used off-label as a treatment
    for IPF including but not limited to d-penicillamine, colchicine, bosentan,
    N-acetyl-cysteine (NAC), imatinib mesylate, and Interferon gamma-1b (IFN-γ 1b)
    E.5 End points
    E.5.1Primary end point(s)
    The absolute change in percent predicted FVC from baseline to week 60.
    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 No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 months10
    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 months10
    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 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 2006-04-06. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 260
    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 Decision2006-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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