None listed
Conditions
Interventions
GLOBAL AMENDMENT #2 ALLOWS PATIENTS FROM OTHER QUALIFYING INTERMUNE CLINICAL TRIALS OF PIRFENIDONE TO ENROLL IN PIPF-012 ONCE THEY HAVE COMPLETED THEIR ORIGINAL STUDY REQUIREMENTS. THE EFFECTIVE DATE
Sponsors
InterMune, Inc.,
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. COMPLETES THE QUALIFYING CLINICAL STUDY FINAL VISIT 2. IN THE OPINION OF THE PI, HAS BEEN GENERALLY COMPLIANT WITH STUDY REQUIREMENTS DURING THE QUALIFYING STUDY, OR MUST BE CONSIDERED ELIGIBLE TO ENROLL IN PIPF¬012 BY THE INTERMUNE MEDICAL MONITOR 3. IS ABLE TO PROVIDE INFORMED CONSENT AND COMPLY WITH THE REQUIREMENTS OF THE STUDY 3.3.2
Exclusion criteria
Exclusion criteria: 1. IS PREGNANT OR LACTATING. 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). 2. HAS KNOWN HYPERSENSITIVITY TO ANY OF THE COMPONENTS OF THE STUDY DRUG 3. STARTS PARTICIPATION IN ANOTHER INTERVENTIONAL CLINICAL TRIAL BETWEEN THE END OF PARTICIPATION IN THE QUALIFYING INTERMUNE CLINICAL TRIAL AND ENTRY INTO PIPF-012 4. RECEIVES THE FOLLOWING THERAPIES WITHIN 28 DAYS BEFORE THE FIRST DOSE OF STUDY DRUG IN PIPF-012 (DAY 1) OR IS UNWILLING TO REFRAIN FROM USING THESE THERAPIES DURING THE STUDY: A. INVESTIGATIONAL THERAPY DEFINED AS ANY DRUG THAT HAS NOT BEEN APPROVED FOR MARKETING FOR ANY INDICATION IN THE COUNTRY OF THE PARTICIPATING SITE B. FLUVOXAMINE 5. PERMANENTLY DISCONTINUES STUDY DRUG DURING THE QUALIFYING STUDY FOR ANY REASON BEFORE STUDY COMPLETION
Countries
United States
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed