The effects of epidermal growth factor receptor inhibition on pulmonary arterial hypertension associated with systemic sclerosis

VU University Medical Centre (The Netherlands)0 个研究点目标入组 20 人开始时间: 2007年2月1日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•A subject is eligible for inclusion in this study only if all of the following criteria apply:
•1. Written informed consent
•2. Systemic sclerosis
•3. Pulmonary Arterial Hypertension (PAH) with a mean Pulmonary Arterial Pressure (PAP) of above 25 mmHg measured during rest
•4. Pulmonary Vascular Resistance (PVR) above 300 dynes
•5. Total Lung Capacity (TLC) more than 70%
•6. New York Heart Association (NYHA) class III and/or six-Minute Walk Test (6-MWT) less than 80% predicted
•7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment
•8. Stability on medication during the previous three months (defined as stable or decrease of 6-MWT after three months of treatment)

•A subject will be excluded from this study in case of the following criteria:
•1. Left ventricular dysfunction
•2. Valvular heart disease
•3. Pericardial constriction
•4. Wedge pressure more than or equal to 15 mmHg
•5. Chronic thromboembolic pulmonary hypertension
•6. Uncontrolled sleep apnea
•7. History of malignancies
•8. Overt right heart failure
•9. History or presence of skin ulcerations
•10. Women Of Child-Bearing potential (WOCB) who are unwilling or unable to use contraceptives
•11. Sexually active fertile man not using effective birth control if their partners are WOCB
•12. Severe abnormality of the cornea
•13. Inadequate haematologic function defined by an absolute neutrophil count less than 1,500/mm^3, platelet count less than 80,000/mm^3 and haemoblobin level of less than 9 g/dL
•14. Inadequate hepatic function defined by a total bilirubin level 1.5 times the Upper Limit of Normal (ULN) and ASpartate AminoTransferase (ASAT) levels 2.5 times ULN
•15. Inadequate renal function defined by a serum creatinine level more than 1.5 times ULN (alternative: Cockroft less than 50 ml/min)
•16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole

发起方

VU University Medical Centre (The Netherlands)