AN OPEN-LABEL EXTENSION STUDY OF THE LONG-TERM SAFETY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)

InterMune, Inc.,0 个研究点目标入组 36 人开始时间: 2012年12月18日最近更新: 2023年9月4日

试验速览

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•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

•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

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