EUCTR2015-005453-13-ES进行中（未招募）1 期
PILOT STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF GRAZOPREVIR + ELBASVIR FOR 12 OR 16 WEEKS IN LIVER TRANSPLANT RECIPIENTS - EGRADICATE
Fundació clínic per a la Recerca Biomèdica0 个研究点开始时间: 2016年7月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •-Age between 18 and 78 year-old.
- •-Previous liver transplantation (more than 6 months).
- •-Genotype 1 and 4 infection.
- •-Hepatitis C recurrence defined by the presence of abnormal liver function tests, positive HCV-RNA, histological signs of hepatitis C recurrence.
- •-Viral load = 10000 UI/mL.
- •-Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, =10mg/d).
- •-Treatment naïve or treatment experienced (Peg-RBV or triple therapy)
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •-Genotype 2, 3, 5 or 6 infection.
- •-Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
- •-Hepatocellular carcinoma after liver transplantation.
- •-Total bilirubin > 3 mg/dL.
- •-Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
- •-Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
- •-Platelets < 75 x 109 cells/L.
- •-Neutrophil count < 0.5 x 109 cells/L.
- •-Hemoglobin < 9 g/dL.
- •-Albumin < 3g/dL.
- •-HIV infection.
- •-Hepatitis B infection.
- •-Active intake of toxic amounts of alcohol or recreational drugs.
- •-Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
- •-Intake of disallowed medications including(but not limited to):
- •1.Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
- •2.Antifungals: itraconazole, ketoconazole, voriconazole
- •3.Antihypertensives: nifedipine
- •4.Anticonvulsants: carbamazepine, phenytoin, phenobarbital
- •5.Bosentan
- •6.Modafinil
- •7.St.Jonh’s Wort
- •8.Immunosuppressants: cyclosporin, everolimus, sirolimus
- •9.Diabetes agents: glibenclamide, glyburide
- •10.Lipid lowering agents: gemfibrozil
- •11.Eltrombopag
- •12.Lapatinib
- •13.HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
- •14.Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
研究者
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