NCT02890719撤回3 期
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
Fundacion Clinic per a la Recerca Biomédica0 个研究点开始时间: 2016年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Sustained virological response
研究概览
简要总结
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 78 year-old.
- •Previous liver transplantation(more than 6 month).
- •Genotype 1 and 4 infection.
- •Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.
- •Viral load ≥10000UI/mL.
- •Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10 mg/d).
- •Treatment naïve or treatment experienced (Peg-RBV or triple therapy).
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):
- •Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
- •Antifungals: itraconazole, ketoconazole, voriconazole
- •Antihypertensives: nifedipine
- •Anticonvulsants: carbamazepine, phenytoin, phenobarbital
- •St.Jonh's Wort
- •Immunosuppressants: cyclosporin, everolimus, sirolimus
- •Diabetes agents: glibenclamide, glyburide
- •Lipid lowering agents: gemfibrozil
- •Eltrombopag
- •HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
- •Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
研究组 & 干预措施
Genotype 1B
Experimental
treatment 12 weeks
干预措施: Grazoprevir 100 mg/day (Drug)
Genotype 1B
Experimental
treatment 12 weeks
干预措施: Elbasvir 50 mg/d (Drug)
Genotype 1A and 4
Experimental
treatment 16 weeks
干预措施: Grazoprevir 100 mg/day (Drug)
Genotype 1A and 4
Experimental
treatment 16 weeks
干预措施: Elbasvir 50 mg/day (Drug)
Genotype 1A and 4
Experimental
treatment 16 weeks
干预措施: Ribavirin 1200 mg/day (Drug)
结局指标
主要结局
Sustained virological response
时间窗: 12 weeks post-treatment
Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.
次要结局
- Sustained virological response(4 weeks and 24 weeks post-treatment)
- To assess the impact of therapy in kidney function.(24 weeks post-treatment)
- To evaluate the beneficial effects of antiviral therapy on renal function.(24 weeks post-treatment)
- Tolerability of this combination in liver transplant recipients.(Every visit)
研究者
Anna Cruceta
Xavier Forns
Fundacion Clinic per a la Recerca Biomédica
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