NL-OMON30491撤回2 期
The Effects of Epidermal Growth Factor Receptor (EGFR) Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis A phase II controlled open-label safety and efficacy study. - EGFR inhibition in SSc-PAH
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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. PAH with a mean PAP of above 25 mmHg measured during rest.
- •4. PVR above 300 dynes
- •5. TLC > 70 %
- •6. NYHA class III and/or 6 Minute Walk Test < 80% predicted
- •7.Conventional PAH treatment and/or bosentan and/or sildenafil treatment
- •8. Stability on medication during the previous 3 months (defined as stable or decrease of 6 MWT after 3 months of treatment).
排除标准
- •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 >/= 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 hematologic function defined by an absolute neutrophil count < 1,500/mm3, platelet count < 80.000/mm3 and hemoblobin level of < 9 g/dL
- •14.-Inadequate hepatic function defined by a total bilirubin level 1.5 times the upper limit of normal (ULN) and ASAT levels 2.5 times ULN
- •15. Inadequate renal function defined by a serum creatinine level > 1,5 times ULN (alternative: Cockroft <50 ml/min).
- •16. Substances that inhibit CYP3A4 activity, such as rifampicin, phenytoin, ketoconazole, itraconazole (see section 6.4.5)
- •17. Severe interstitial fibrosis on HRCT
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