The Early Use of Sanvar® With Endoscopic Treatment for the Control of Acute Variceal Bleeding Due to Portal Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 37
- 主要终点
- To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival.
研究概览
简要总结
The main objective of this study is to determine the efficacy of early administration of Sanvar® in combination with endoscopic treatment for the control of acute variceal bleeding.
详细描述
This is a single-arm open-label clinical study with historical controls using Sanvar® (vapreotide) administered for 5 days in patients with acute variceal bleeding due to portal hypertension.
Cirrhotic patients with a history of acute hematemesis and/or melena admitted to the emergency unit and meeting the eligibility criteria will receive, as soon as possible after admission (within a maximum of 24 hours after onset of hemorrhage and within 6 hours after admission), Sanvar® (vapreotide acetate) 50 µg IV bolus followed by an IV continuous infusion of 50 µg/h for 5 days.
The diagnostic and therapeutic endoscopy will be performed as soon as possible after the initiation of the study drug infusion, but no more than 12 hours after the patient's admission to the study center. A final follow up will be performed on Day 42.
Patients for whom the source of bleeding is determined at endoscopy to be due to a cause other than portal hypertension (e.g. gastric ulcer) will be replaced. In addition, in such cases the study medication will be discontinued and patients will receive standard treatment according to the cause of their bleeding. These patients will be followed up for safety only.
*Note: There is no provision in this study to have an expanded access program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male cirrhotic patient aged 18 to 75 years.
- •Hematemesis and/or melena (suspected to be caused by portal hypertension)
- •Time interval <=24 hours between onset of initial hemorrhage and initiation of study drug infusion.
- •Time interval <=6 hours between admission and initiation of study drug infusion.
- •Anticipated time interval<=12 hours between admission and end of therapeutic endoscopy.
- •Unequivocal history of cirrhosis, either documented by at least one of classical clinical signs (abdominal collateral venous circulation, firm liver with a sharp lower liver edge, presence of spider naevi, and/or ascites), or by biochemical and/or Doppler-US signs.
- •Written informed consent obtained by the patient or his/her relative(s)
排除标准
- •Patient previously included in this study for a prior bleeding episode.
- •Patients treated with a vasoactive drug such as octreotide, vasopressin or its analogue for the current episode of bleeding.
- •Hepatic encephalopathy Grade IV.
- •Balloon tamponade already positioned at admission.
- •Known Child-Pugh score >=13
- •Pregnant or breast-feeding women.
- •Known diffuse hepatocellular carcinoma.
- •Known complete portal venous thrombosis.
- •Bleeding from esophageal varices within the previous 6 weeks.
- •Patient currently enrolled in another therapeutic study, and/or who participated in another clinical study, within the previous 6 weeks.
- •Known allergy to somatostatin or somatostatin analogues.
- •Previous porto-systemic shunt (TIPS) or orthotopic liver transplantation.
- •Patient with known cancer.
- •Patient with known chronic renal failure (serum creatinine > 1.5 mg/dl).
- •Severe concomitant disease judged by the Investigator as being incompatible with evaluation of treatment.
结局指标
主要结局
To determine the efficacy of the early administration of Sanvar® (vapreotide) in association with endoscopic treatment for the control of bleeding at 5 days, i.e. control of initial bleeding and prevention of early re-bleeding, plus survival.
时间窗: 5 days
次要结局
- To assess the following:
- The effect of drug administration before endoscopy assessed by the endoscopic facilitation and control of bleeding at endoscopy,(Endoscopy)
- Control of bleeding 6 hours after infusion of the study drug (= Tinf + 6h),(Tinf + 6h)
- Control of bleeding by time periods (Tendo+6h, Tendo+48h and Tendo+ 120h) by Child Pugh class,(Tendo+6h, Tendo+48h and Tendo+ 120h)
- Number of blood units administered during the 5 days of drug infusion,(5 days)
- Safety of treatment(42 days)