EUCTR2014-005523-27-ES进行中（未招募）1 期
Multicenter prospective randomized trial of the effect of rivaroxaban on survival and development of complications of portal hypertension in patients with cirrhosis - CIRROXABA
INSTITUTO DE INVESTIGACIONES BIOMEDICAS AUGUST PI I SUNYER (IDIBAPS)0 个研究点目标入组 160 人开始时间: 2015年7月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •a. Aged between 18 and 75 years of both sexes.
- •b. Clinical and / or laboratory criteria, ultrasound and / or liver biopsy compatible with the diagnosis of viral cirrhosis (If HBV: HBV-DNA must be negative; if HCV: SVR should be at least for 6 months prior to enrollment); alcohol (in the last 6 months: in men less than 60 g daily intake in women less than 40 g); NASH and cryptogenic.
- •c. Presence of clinically significant portal hypertension (CSPHT) defined by clinical criteria (presence of esophageal varices or ascites), elastography (liver Fibroscan® ? 21 kPa) or hemodynamic (HVPG ? 10 mmHg)
- •d. Mild to moderate hepatic impairment defined by Child-Pugh of 7-10 points.
- •e. Written informed consent to participate in the study
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •a. Any previous or current thrombosis in splenoportal axis (must be ruled out by US-Doppler earlier than one month after randomization; if doubts: AngioCT or AngioMRI if required).
- •b. Background of hepatic encephalopathy grade II or higher
- •c. Ascites that required prior practice of paracentesis in the last year
- •d. Indication for use of anticoagulant and / or antiplatelet therapy for any reason.
- •e. Hypersensitivity to the active ingredient or to excipients
- •f. Active bleeding, clinically significant, or risk of major bleeding.
- •g. Pregnancy and lactation.
- •h. HCC or malignant neoplasia at the time of inclusion.
- •i. Any comorbidity involving a therapeutic limitation and/or a life expectancy <12 months.
- •j. Existence of risk bleeding esophageal varices or prior variceal bleeding. They may not be included untill full treatment (stable beta blockers dosage or eradication trough varices ligation).
- •k. Pregnancy or lactation.
- •l. Severe thrombocytopenia <40,000 platelets / dl.
- •m. Kidney failure (creatinine clearance <15ml / min).
- •n. TIPS or portosystemic shunt carrier.
- •o. Child-Pugh score greater than 10.
- •p. In HCV liver cirrosis patients: not carrying at least six months in SVR. In HBV liver cirrosis patients: HBV DNA is not negative .
- •q. Active alcoholism (60 g / day in men and 40 in women)
- •r. Use of potent inhibitors of cytochrome CYP450 3A4 (ketoconazole, protease inhibitor antiretroviral treatment in HIV patients) or cytochrome inductors (rifampicin. Phenytoin ...).
- •s. Participation in another clinical trial
研究者
相似试验
已完成
3 期
Prospective multicenter randomized trial on the effects of Lanthanum Carbonate in hemodialysis patients compared with Calcium Carbonate on coronary artery calcification: Landmark Subsidiary StudyHemodialysis patients with hyperphosphatemiaJPRN-UMIN000006816andmark Study Group400
已完成
不适用
Randomised prospective multicentre trial on the effect of early enteral nutrition on gut barrier permeability in severe acute pancreatitisDigestive SystemAcute pancreatitisSevere acute pancreatitisISRCTN12838218Barts and the London NHS Trust (UK)66
尚未招募
不适用
A Prospective randomized multi-center study for efficacy of metallic biliary stent compared to plastic stent in patients receiving neoadjuvant chemotherapy for resectable pancreatic cancerKCT0006294Yonsei University Health System, Severance Hospital196
未知
不适用
Multicentre randomized controlled trial on the effects of a preventive intervention of postpartum interpersonal relationships disorder (PIRD)PregnantJPRN-UMIN000019064Kitamura Institute of Mental Health Tokyo400
进行中（未招募）
1 期
Study of the efficacy of early intervention with secukinumab 300 mg s.c. compared to narrow-band UVB in patients with new-onset moderate to severe plaque psoriasisPlaque psoriasisEUCTR2015-002423-26-SEovartis Pharma Services AG196