EUCTR2010-019883-36-HU进行中（未招募）不适用
A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
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. Written informed consent must be obtained before any assessment is performed
- •2. Male or female 18 years of age or older who are unable to bear children and females of child bearing potential not disqualified as per Exclusion Criterion 1 (below)
- •3. WHO Functional Class II or III
- •4. 6MWD = 150 m and = 450 m at screening. Distances of two consecutive 6MWTs should be within 15% of one another
- •5. A current diagnosis of Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting: WHO Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect (ASD, VSD or PDA), or PAH associated with diet therapies or other drugs
- •6. Inadequate clinical response despite stabilization on one or more class(es) of PAH drug [e.g., PDE5 inhibitor, endothelin receptor blocker, vasodilator prostaglandin (systemic, inhaled or oral)]
- •7. Stabilization of pulmonary hypertension medications defined as observed for = 2 months on approved therapeutic dose of at least one PAH drug and still symptomatic with WHO functional Class II or III performance.
- •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. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are:
- •a)women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- •b)women whose partners have been sterilized by vasectomy or other means
- •c)using two birth control methods.
- •2. Pregnant or nursing (lactating) women
- •3. History of ventricular tachycardia, ventricular fibrillation or ventricular flutter
- •4. Use of drugs known to prolong the QT interval or known to be strong CYP3A4 inhibitors
- •5. Untreated or inadequately controlled hypokalemia or hypomagnesemia at Visit 1
- •6. Evidence of clinically significant left ventricular dysfunction.
- •7. Evidence of clinically significant hepatic impairment
- •8. Atrial fibrillation or history of atrial fibrillation in the previous 3 months
- •9. Having syncope in the 3 months prior to the screening visit
- •10. History of previous myocardial infarction or unresolved ischemia
- •11. QRS > 120 ms or > 140 ms in the presence of bundle branch block
- •12. Current or history of long QT syndrome or QTc > 450 ms for males and > 470 ms for females at screening or baseline
- •13. WHO Class IV
- •14. History of Torsades de Pointes
- •15. In treatment with chronic nitric oxide therapy
- •16. Pre-existing lung disease
- •17. With a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction
- •18. Diagnosis of pulmonary artery or vein stenosis
- •19. With other diagnosis of PAH in WHO Diagnostic Group 1 are excluded
- •20. With a diagnosis of PAH associated with venous hypertension, hypoxia, chronic pulmonary thromboembolic disease or other miscellaneous causes
- •21. Thrombocytopenia < 50 x109/L (50 x 103/µL)
- •22. History of acute left sided heart failure or chronic left sided heart failure present at screening
- •23. Uncontrolled systemic arterial hypertension, systolic > 160 mm Hg or diastolic >90 mm Hg
- •24. Hemoglobin < 100 g/L (10 g/dL) at the screening visit (Visit 1)
- •25. Deficiencies of blood coagulation, inherited or acquired blood coagulation disorders, factor XII, factor XIII; decreased generation of coagulation factors due to acute or chronic liver diseases, efficient coagulation due to auto-antibodies against coagulation factors such as in lupus anticoagulant
- •26. Disseminated intravascular coagulation
- •27. Evidence of major bleeding or intracranial hemorrhage
- •28. History of elevated intracranial pressure
- •29. History of latent bleeding risk
- •30. Previous therapeutic radiation of lungs or mediastinum
- •31. History of sickle cell anemia
- •32. Having undergone atrial septostomy in the 3 months prior to the screening visit
- •33. Previously undergone radiofrequency catheter ablation for atrial or sinus arrhythmias in the 3 months prior to screening visit
- •34. An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations
- •35. History of immunodeficiency diseases, including HIV
- •36. History of pancreatitis.
- •37. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •38. Disability that may prevent the patient from completing all study requirements
- •39. Life expectancy of 6 months or less
- •40. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •41. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years
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