None listed
Conditions
Interventions
APPROXIMATELY 500 PATIENTS WILL BE RANDOMIZED WITH EQUAL PROBABILITY TO RECEIVE PIRFENIDONE 2403 MG/D OR PLACEBO. THE PRIMARY EFFICACY ENDPOINT IS THE CHANGE FROM BASELINE IN % FVC. PATIENTS WILL RECE
50% AND ≤
90% AND PERCENT PREDICTED CARBON MONOXIDE DIFFUSING CAPACITY (% DLCO) ≥
30% AND ≤
90% AT SCREENING, AS WEL AS 6MWT DISTANCE ≥
150 METERS AT SCREENING. ANY PATIENT IDENTIFIED FOR THE STUDY MUST DISCONTINUE ALL PROHIBITED THERAPIES INCLUDING THERAPY TARGERED TO TREAT IPF FOR AT LEAST 28 DAYS BEFORE THE START OF SCREENING. OTHE
Sponsors
InterMune, Inc.,
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Countries
United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed