A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS

InterMune, Inc.,0 个研究点目标入组 44 人开始时间: 2011年10月28日最近更新: 2023年9月4日

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•DIAGNOSIS OF IPF:
•1. CLINICAL SYMPTOMS ONSISTENT WITH IPF OF ≥ 12 MONTHS DURATION.
•2. DIAGNOSIS OF IPF, DEFINED AS THE FIRST INSTANCE IN WHICH A PATIENT WAS INFORMED OF HAVING IPF, AT LEAST 6 MONTHS AND NO MORE THAN 48 MONTHS BEFORE RANDOMIZATION.
•3. AGE 40 THROUGH 80 YEARS, INCLUSIVE, AT RANDOMIZATION.
•4. DIAGNOSIS OF UIP OR IPF BY HRCT AND SLB AS OUTLINED IN TABLE 3-1.
•(NOTE: HRCT SCAN PERFORMED WITHIN 1 MONTH OF THE START OF SCREENING MAY B USED IF IT MEETS IMAGE ACQUISITION GUIDELINES)
•5. EXTENT OF FIBROTIC CHANGES (HONEYCOMBING, RETICULAR CHANGES) GREATER THAN THE EXTENDED OF EMPHYSEMA ON HRCT SCN, AS DETERMINED BY CENTRAL REVIEW.
•6. NO FEATURES SUPPORTING AN ALTERNATIVE DIAGNOSIS ON TRANSBRONCHIAL BIOPSY, BRONCHOALVEOLAR LAVAGE (BAL), OR SLB, IS PERFORMED.
•IPF: DISEASE SEVERITY AND PROGRESSION:
•7. % FVC ≥ 50% and ≤ 90% AT SCREENING, CONFIRMED BY CENTRAL REVIEW.

•DISEASE-RELATED EXCLUSIONS:
•1. SIGNIFICANT CLINICAL WORSENING OF IPF BETWEEN SCREENING AND DAY 1, IN THE OPINION OF THE INVESTIGATOR.
•2. NOT A SUITABLE CANDIDATE FOR ENROLLMENT OR UNLIKELY TO COMPLY WITH THE REQUIREMENTS OF THIS STUDY, IN THE OPINION OF THE INVESTIGATOR.
•3. FORCED EXPIRATORY VOLUME IN ONE SECOND (FEV₁)/FVC RATIO < 0.8 AFTER ADMINISTRATION OF BRONCHODILATOR AT SCREENING, CONFIRMED BY CENTRAL REVIEW.
•4. BRONCHODILATOR RESPONSE, DEFINED BY AN ABSOLUTE INCREASE OF ≥ 12% AND AN INCREASE OF 200 ML IN TH PREDICTED FEV₁ OR FVC OR BOTH AFTER BRONCHODILATOR USE COMPARED WITH THE VALUES SEN BEFORE BRONCHODILATOR USE AT SCREENING, CONFIRMED BY CENTRAL REVIEW.
•5. CIGARETTE SMOKING WITHIN 3 MONTHS OF SCREENING OR UNWILLING TO AVOID TOBACCO PRODUCTS THROUGHOUT THE STUDY.
•6. HISTORY OF CLINICALLY SIGNIFICANT ENVIRONMENTAL EXPOSURE KNOWN TO CAUSE PF, INCLUDING BUT NOT LIMITED TO DRUGS (SUCH AS AMIODARONE), ASBESTOS, BERYLLIUM, RADIATION AND DOMESTIC BIRDS.

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