EUCTR2009-011324-60-DE进行中（未招募）不适用
Prospective randomized trial to compare a twice daily to a once daily administration of the Tacrolimus in lung transplanted patients - Advagraf-Study
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
- 48
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
- •Pts more than1 year after single lung, double lung or heart/lung transplantation and
- •Pts treated with ciclosporin, steroids and MMF and
- •Pts =18 and = 70 years and
- •Pts with one oft he following
- •Pts with recurrent acute rejections (RAR)
- •?two or more acute rejections in 3 months (first 3 years post Tx,
- •6 months (>3 years post Tx) defined by
- •transbronchial biopsy >A1 (or A1 with clinical criteria
- •below)nach ISHLT (B>1R) or
- •decline of FEV1 > 10 % baseline after exclusion of infection, airway complication, effusion etc. and improvement to steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) = FEV1 improvement > 10% compared to the last measurement before AR treatment
- •Pts with steroid-resistant or ongoing acute rejections (OAR) defined by
- •?transbronchial biopsy >A1 (or A1 with clinical criteria above) at
- •least 4 weeks following steroid-pulse therapy
- •(methylprednisolone 15 mg/kg for three days) or
- •?no FEV1 improvement (< 5% baseline) at least 14 days
- •following ACR steroid-pulse therapy (methylprednisolone 15
- •mg/kg for three days) after exclusion of infection, airway
- •complication, effusion etc. or
- •Pts with new onset of BOS (nBOS)
- •Unexplained FEV1 < 80% of baseline after exclusion of
- •Infection, airway complication, effusion etc
- •Pts with CyA associated side effects (e.g. hyperlipidaemia,
- •hypertriglyceridemia, hypertension, hirsutism, gingival hyperplasia)
- •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
- •Pregnant or breast feeding women
- •Pts who are not using a double-barrier method of birth control
- •Pts with systemic infections
- •Pts with severe diarrhea, vomiting, active ulcer
- •Pts with severe liver disease or liver cirrhosis
- •Pts with m-Tor inhibitors
- •Pts with hypersensitivity to Tacrolimus, other macrolides or other tablet ingredients.
研究者
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