EUCTR2007-007800-13-FR进行中（未招募）不适用
An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies - Open-Label Extension of Pirfenidone CAPACITY Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 who meets all of the following criteria is eligible to participate in the study:
- •1. Completes the CAPACITY studies Final Follow-Up Visit
- •2. In the opinion of the 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
- •Any patient who meets any of the following criteria is not eligible to participate in the study:
- •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.
- •4. Participates in another interventional clinical trial between the end of participation in the CAPACITY studies 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 hydroxymethylglutaryl-coenzyme 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, cytokine modulating, or receptor antagonist agent including but not limited to:
- •bosentan, cyclosporine, etanercept, iloprost, infliximab, leukotrienes, methotrexate, mycophenolate mofetil, sildenafil (daily), tetrathiomolybdate, TNF-a inhibitors, N-acetylcysteine (NAC) alone, imatinib mesylate, Interferon gamma-1b (IFN g 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 ATS/ERS 2005 Guidelines and (b) NAC in combination with prednisone and azathioprine.
- •6. Permanently discontinues study drug in the CAPACITY studies for any reason
- •7. Meets any of the following liver function test criteria above specified limits at the CAPACITY Treatment Completion Visit: total bilirubin >2.5 x upper limit of normal (ULN); aspartate or alanine aminotransferases (AST/SGOT or ALT/SGPT) >2.5 x ULN; alkaline phosphatase >2.5 x ULN
- •8. Has an ECG from a CAPACITY Trials Treatment Completion Visit or from the PIPF-012 Day 1 Visits showing heart-rate–correct (using Bazett’s formula) QT (QTcB) interval >500 ms or must obtain permission from the InterMune medical monitor
研究者
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