EUCTR2006-000138-11-IE进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiophatic Pulmonary Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •1. Clinical symptoms consistent with IPF, including the insidious onset of
- •otherwise unexplained dyspnea on exertion, of more or equal to 3 months duration
- •2. Diagnosis of IPF, defined as first instance in which a patient was informed of
- •having IPF, within 48 months of randomization
- •3. Age 40 through 80 years, inclusive
- •4. High-resolution computed tomographic (HRCT) scan showing a pattern of
- •disease consistent with a confident (definite) radiographic diagnosis of usual
- •interstitial pneumonia (UIP)/IPF. For patients with surgical lung biopsy showing
- •definite or probable UIP, the HRCT criterion of probable (UIP)/IPF is sufficient.
- •5. For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung
- •biopsy showing definite or probable UIP within 48 months of randomization. In
- •addition, there are no features supporting an alternative diagnosis on
- •transbronchial biopsy or bronchoalveolar lavage (BAL), if performed .
- •6. For patients aged more than or equal to 50 years: At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months of randomization.
- •a. Open or VATS lung biopsy showing definite or probable UIP.
- •b. Transbronchial biopsy showing no features to support an alternative
- •diagnosis. These alternative diagnoses include but are not limited to
- •granulomatous disease, sarcoidosis, and hypersensitivity pneumonitis.
- •c. BAL showing no features to support an alternative diagnosis
- •7. FVC more or equal to 50% of predicted value
- •8. Hemoglobin (Hb)-corrected carbon monoxide diffusing capacity/carbon
- •monoxide transfer capacity (DLCO /TLCO) more or equal to 35% of predicted value
- •9. Either FVC or Hb-corrected DLCO /TLCO less or equal to 90% of predicted value
- •10. No evidence of improvement in measures of IPF disease severity over the
- •preceding year
- •11. Distance walked more or equal to 150 meters (492 feet) with O2 saturation more or equal to 83% on less or equal to 6 L/min of O2 during the 6-Minute Walk Test (6MWT) oxygen titration procedure performed during screening
- •12. Able to understand and sign a written informed consent form
- •13. Able to understand the importance of adherence to study treatment and the study protocol, including the concomitant medication restrictions throughout the Study Period
- •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
- •1. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
- •2. Premature withdrawal from a randomized IPF clinical trial in the previous 2 years for any reason other than Sponsor decision or current participation in a clinical drug trial
- •3. Forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 after administration of bronchodilator
- •4. Bronchodilator Response defined by an absolute increase in FEV1 or FVC of >12% predicted or 200 mL after bronchodilator use
- •5. The change in FVC between the Screen Visit and Day 1 (Baseline) cannot vary by more than 10% absolute difference and the Bronchodilator Response, Baseline FVC and FEV1/FVC ratio must all continue to meet the inclusion and exclusion criteria
- •6. Residual volume (RV) >120% of predicted (before administration of bronchodilator)
- •7. History of clinically significant environmental exposure known to cause PF (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds)
- •8. Known explanation for interstitial lung disease, including but not limited to
- •radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis and cancer
- •9. Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis
- •10. Clinical evidence of active infection, including but not limited to bronchitis,
- •pneumonia, sinusitis, urinary tract infection, or cellulitis
- •11. On a lung transplantation waiting list at time of randomization
- •12. Unable to undergo pulmonary function testing
- •13. Any history of malignancy likely to result in death or significant disability or
- •likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized carcinoma (e.g., basal cell carcinoma)
- •14. Any condition other than IPF which, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years
- •15. History of advanced cirrhosis or clinically significant liver disease
- •16. History of unstable or deteriorating cardiac or pulmonary disease (other than
- •IPF) within the previous 6 months, including but not limited to the following:
- •a. Myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, or coronary angioplasty
- •b. Congestive heart failure requiring hospitalization
- •c. Uncontrolled arrhythmias
- •d. Asthma or chronic bronchitis requiring hospitalization in the last 6 months
- •17. Any condition, which, in the opinion of the investigator, might be significantly
- •exacerbated by the known side effects associated with the administration of
- •pirfenidone
- •18. Poorly controlled diabetes (defined by glycosolated hemoglobin [HbA1C] >10)
- •19. Pregnancy or lactation. Women of childbearing capacity are required to have a
- •negative serum pregnancy test before treatment and must agree to practice
- •abstinence or prevent pregnancy by two methods of birth control from the date
- •of screening through the duration of the study (i.e. oral contraception and a spermicide, diaphragm and a spermicide, etc.).
- •20. History of alcohol or substance abuse in the past 2 years
- •21. History of any condition or habit associated with altered consciousness and a
- •risk of aspiration in the past 2 years
- •22. Family or personal history of long QT-wave syndrome
- •23. Any of the following liv
研究者
相似试验
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPERheumatoid ArthritisEUCTR2007-007539-14-PLAstraZeneca AB360
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPEMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2007-007539-14-MTAstraZeneca AB360
进行中（未招募）
1 期
A Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.Severe Acute Decompensated Alcoholic HepatitisMedDRA version: 20.0 Level: LLT Classification code 10001624 Term: Alcoholic hepatitis System Organ Class: 100000004871EUCTR2018-000819-25-LVAfimmune126
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients with Idiopathic Pulmonary FibrosisEUCTR2006-000138-11-DEInterMune, Inc.260
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - EscapeMale and female patients over 18 years of age, with active RA despite current treatment with methotrexate. All patients will continue with background methotrexate therapy.MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2007-007539-14-ITASTRAZENECA360