NCT01188733已完成1 期
Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 39
研究概览
简要总结
Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.
In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
- •presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
- •age ≥ 18 years
排除标准
- •pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
- •allergic to sandostatin
- •high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
- •Child Turcotte Pugh Class C cirrhosis
- •hepatocellular carcinoma
- •evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
- •serum creatinine greater than 2 mg/dL
- •platelet count below 50,000 per microliter
- •prothrombin time 4 seconds or more greater than control
- •human immunodeficiency virus (HIV) positive
- •symptomatic gallstones
- •previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
- •previous history of variceal bleeding
- •history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
- •use of any investigational drug within 1 month prior to screening and
- •current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).
研究组 & 干预措施
Saline
Placebo Comparator
Saline control
干预措施: Saline (Drug)
Sandostatin LAR 10mg
Experimental
Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
干预措施: Long acting octreotide 10mg (Drug)
Sandostatin LAR 30mg
Experimental
Comparison of drug doses
干预措施: Long acting Octreotide 30mg (Drug)
研究者
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