EUCTR2007-007800-13-IT进行中（未招募）不适用
Studio di estensione in aperto sulla sicurezza a lungo termine del pirfenidone nei pazienti con fibrosi polmonare idiopatica (FPI) che hanno completato gli studi CAPACITY - ND
INTERMUNE0 个研究点目标入组 750 人开始时间: 2008年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient must fulfill all of the following criteria to be
- •eligible for enrollment into the study:
- •1. Completes the CAPACITY studies Final Follow-Up
- •2. In the opinion of the principal investigator (PI), has
- •been at least 80% compliant with taking the study
- •drug at the time of the CAPACITY Treatment
- •Completion Visit, or must obtain permission from
- •the InterMune medical monitor
- •3. Is able to provide informed consent and comply
- •with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient with any of the following will be excluded from the
- •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. In the opinion of the PI, is not a suitable candidate
- •for study participation. The PI should carefully
- •consider the risks and benefits of treatment if the
- •patient?s medical status has declined significantly
- •during participation in CAPACITY. The exclusion
- •criteria from the CAPACITY studies are provided in
- •Appendix C for reference
- •4. Participates in another interventional clinical trial
- •between the end of participation in either PIPF-004
- •or PIPF-006 and planned entry into PIPF-012.
- •5. Receives the following therapies within 28 days of
- •the first dose of pirfenidone in this study (Day 1):
- •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. Angiotensin-converting enzyme (ACE)-
- •inhibitors, colchicine, warfarin, heparin,
- •sildenafil, and hydroxymethylglutarylcoenzyme
- •A (HMG-CoA) reductase inhibitors.
- •These drugs may be used if given for a non-IPF
- •indication if there is no clinically acceptable
- •alternative therapy for the same indication.
- •c. Any cytotoxic, immunosuppressive, cytokinemodulating,
- •or receptor antagonist agent,
- •including but not limited to the following:
- •bosentan, cyclosporine, etanercept, iloprost,
- •infliximab, leukotrienes, methotrexate,
- •mycophenolate mofetil, sildenafil (daily),
- •tetrathiomolybdate, tumor necrosis factor alpha
- •(TNF-α) inhibitors, N-acetylcysteine (NAC)
- •alone, imatinib mesylate, Interferon gamma-1b
- •(IFN-γ 1b), and tyrosine kinase inhibitors. These
- •drugs may be used if given for a non-IPF indication if there is no clinically acceptable
- •alternative therapy for the same indication.
- •Note: the exceptions are (a) corticosteroids,
- •azathioprine, and/or cyclosphosphamide at
- •doses specified in the American Thoracic
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