An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung Disease - LOTUSS

InterMune Inc.0 个研究点目标入组 50 人开始时间: 2013年7月4日最近更新: 2015年7月10日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: InterMune Inc.
入组人数: 50

研究概览入排标准研究者记录与标识符相似试验

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

•Eligible patients are to fulfill the preliminary criteria of the American College of Rheumatology for the classification of SSc (Masi 1980) and have a confirmed diagnosis of SSc-ILD based on pulmonary function testing and radiologic data.
•Patients who meet all of the following criteria are eligible to participate in the study:
•Demographic Characteristics:
•1. Male and female patients, aged 18-70 years (inclusive) on Day 1
•SSc- and SSc-ILD-Related Criteria:
•2. Diagnosis of SSc confirmed by the investigator using the preliminary criteria of the American College of Rheumatology for the classification of systemic sclerosis (Masi 1980, Appendix B)
•a. Duration of diagnosis <7 years (dated from the onset of the first non-Raynaud’s phenomenon manifestation, to Day 1 of the study)
•3. Diagnosis of SSc-ILD based on an HRCT scan (obtained in the 2 years before the date of written informed consent) that demonstrates findings consistent with ILD, as assessed by the investigator
•4. Screening FVC =50% of the predicted value, and screening DLCO =40% of the predicted value
•5. At study entry, the patient either is not taking SSc-ILD medication or is taking cyclophosphamide or MMF, as described below:
•a. Not on SSc-ILD medication: Has not taken SSc-ILD medication in the 3 months before Day 1, or will complete appropriate washout of SSc-ILD medication by Day 1; for such patients, there must be no plan to start another SSc-ILD medication during the study
•b. Taking cyclophosphamide or MMF: Is on an oral formulation of cyclophosphamide (=2 mg/kg/d) or MMF (=1.5 g two times daily [BID]), and the dose has been stable in the 3 months before Day 1; for such patients, there must be no plan to change that SSc-ILD medication or its dose during the study
•Informed Consent and Protocol Adherence:
•6. Able to understand and sign a written informed consent form
•7. Able to understand the importance of adhering to study treatment and the study protocol, and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
•8. Use of effective contraception: Women of childbearing potential are required to have a negative pregnancy test before treatment and must agree to maintain highly effective 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, one of the two methods of birth control must be an oral contraceptive (e.g., oral contraceptive and spermicide).
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•1. Clinically significant pulmonary hypertension, based on any of the following criteria:
•a. Receiving treatment for pulmonary hypertension
•b. Or, if available, a previous right heart catheterization that demonstrates mean pulmonary artery pressure at rest of =25 mm Hg with concurrent wedge pressure of =15 mm Hg and pulmonary vascular resistance of >3 Wood units
•c. Or, Doppler echocardiography in the 6 months before D1 with an estimated systolic pulmonary arterial pressure (Ppa) of >36 mm Hg corresponding to a tricuspid regurgitant jet velocity of >2.8 m/sec
•2. Evidence of right atrial or ventricular enlargement or significant left ventricular dysfunction
•3. Known underlying liver disease (e.g., hepatitis or cirrhosis)
•4. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux (UCLA SCTC GIT 2.0 reflux score >1.00), as assessed by the investigator
•5. Known achalasia, esophageal stricture, or esophageal dysfunction sufficient to limit the ability to swallow oral medication
•6. Tobacco smoking within 3 months of screening or unwillingness to avoid smoking throughout the study
•7. History of a clinically significant environmental exposure that is known to cause PF including, but not limited to, drugs (e.g., amiodarone), asbestos, beryllium, radiation, or domestic birds or other factors associated with hypersensitivity pneumonitis
•8. History of clinically significant asthma as an adult or clinically significant chronic obstructive pulmonary disease, as assessed by the investigator
•9. Clinical evidence of active infection including, but not limited to, bronchitis, pneumonia, sinusitis, or UTI.
•10. Features supporting diagnosis of another connective-tissue disorder (e.g., RA or SLE) or another pulmonary disorder (e.g., emphysema, asthma, cancer)
•11. Expected to have study participation interrupted for a foreseeable medical or surgical event (e.g., organ, stem cell, or bone marrow transplant).
•12. Any clinical evidence of a malignancy that is likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months (relative to D1). Excluded: minor surgical procedures for localized cancer (basal cell carcinoma).
•13. Any condition (other than SSc-ILD) likely to result in the death of the patient within 12 months, as assessed by the investigator
•14. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD) within the previous 6 months (relative to D1) including, but not limited to unstable angina pectoris, myocardial infarction, congestive heart failure requiring hospitalization, uncontrolled clinically significant arrhythmia, pulmonary hypertension (see Exclusion Criterion 1)
•15. Any condition that, as assessed by the investigator, might be significantly exacerbated by the known side effects associated with pirfenidone
•16. Known or suspected peptic ulcer
•17. Pregnancy or lactation: Positive pregnancy test; currently lactating; or for women of childbearing potential, an unwillingness to maintain highly effective contraception, as described in Inclusion Criterion 8
•18. History of alcohol or substance abuse in the previous 2 years (relative to D1)
•19. Family or personal history of long QT syndrome
•20. Any of the following liver test criteria above the specified limit:
•a. Total bilirubin above ULN, except in patients with predominantly unconjugated hyperbilirubinemia (Gilbert’s syndrome)
•b. AST or ALT >2 ×

研究者

发起方

InterMune Inc.

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