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    Summary
    EudraCT Number:2006-000138-11
    Sponsor's Protocol Code Number:PIPF-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-10
    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 ConcernedBelgium - FPS Health-DGM
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    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 No
    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. Percent predicted FVC ≥50% at the screen visit and day 1 (before randomisation). The change in FVC (measured in litres) between the screen visit and day 1 must be ≤ 10% relative difference.
    8. Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon monoxide transfer capacity (DLCO /TLCO) more or equal to 35% of predicted value at the screen visit only
    9. Either FVC or Hb-corrected DLCO /TLCO ≤90% of predicted value at the screen visit
    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 suitable for enrolment or unlikely to comply with the requirements of this study in the opinion of the investigator
    2.Premature withdrawal from 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.FEV in the first second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at the screen visit and day 1 before randomisation
    4.Bronchodilator response defined by absolute increase of ≥ to 12% and an increase of 200 mL in the predicted FEV1 or FVC or both after bronchodilator use compared to the values before bronchodilator at the screen visit and day 1 before randomisation
    5. RV >120% of predicted (before administration of bronchodilator)
    6.History of clinically significant environmental exposure known to cause PF (including drugs, asbestos, beryllium, radiation, domestic birds)
    7.Known explanation for interstitial lung disease
    8.Diagnosis of any connective tissue disease, including scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
    9.Clinical evidence of active infection, including bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
    10.In the clinical opinion of the investigator the patient is expected to need and be eligible for a lung transplant within 72 weeks after randomisation.
    11.Unable to undergo pulmonary function testing which includes meeting the following reproducibility standards: At screening the 2 highest acceptable FVC values must be within 0.100 liter; at day 2 the 2 highest acceptable FVC values must be within 0.100 liter; at screening, 2 of the 3 acceptable DLco values must be within 2 units (for TLco, within 0.67 SI units of each other)
    12.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)
    13.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
    14.History of advanced cirrhosis or clinically significant liver disease
    15.History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months including 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
    16.Any condition which in the opinion of the investigator might be significantly exacerbated by the known side effects associated with the administration of pirfenidone
    17.Poorly controlled diabetes (defined by glycosolated hemoglobin [HbA1C] >10)
    18.Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, then one of the two methods of birth control should be an oral contraceptive (e.g oral contraception and a spermicide).
    19.History of alcohol or substance abuse in the past 2 years
    20.History of any condition or habit associated with altered consciousness and a risk of aspiration in the past 2 years
    21.Family or personal history of long QT-wave syndrome
    22.Any of the following liver function test criteria above specified limits: total bilirubin >2.5 x ULN; aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >2.5 x ULN; alkaline phosphatase >2.5 x ULN
    23.Screening or Day 1 ECG with a QTcB interval >500 msec
    24.Prior use of pirfenidone or known hypersensitivity to any of the components of study treatment
    25.Patients are excluded if they require the following therapies within 28 days prior to screening: a. Investigational therapy defined as any drug not approved for marketing for any indication in the country of the participating site b. Any cytotoxic, immunosuppressive, cytokine modulating, or endothelin receptor antagonist agents including: azathioprine, bosentan, cyclophosphamide, corticosteroids, cyclosporine, etanercept, iloprost, infliximab, leukotrienes, methotrexate, mycophenolate mofetil, sildenafil (daily), tetrathiomolybdate, TNF α inhibitors, NAC, imatinib mesylate, IFN-γ 1b, and tyrosine kinase inhibitors c. Concomitant medications used for the treatment of IPF (including): ACE-inhibitors, colchicine, warfarin, heparin, sildenafil, and HMG-CoA reductase inhibitors. These drugs may be used for a non-IPF indication if there is no clinically acceptable alternative therapy for the same indication.
    E.5 End points
    E.5.1Primary end point(s)
    The absolute change in percent predicted FVC from baseline to week 72.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Yes
    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 2006-03-10. 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 Decision2006-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
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