Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BioVie Inc.
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
研究概览
简要总结
Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.
详细描述
Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7 days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be performed to determine steady state concentration of both terlipressin and 8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses.
A total of 6 patients will be treated. Monitoring will include successful management of ascites, with reduction in paracentesis procedures and decreased ascites fluid volume, further supported by improvement in renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis and refractory ascites who required 3 or more large volume (4 liters and more) paracenteses in the previous 60 days
排除标准
- •Ascites with causes other than cirrhosis such as nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
- •Total bilirubin > 5 mg/dL
- •Blood clotting International normalized ratio (INR) > 2.5
- •Serum creatinine > 2.0 mg/dL
- •Current or recent (within 3 months of consent) renal dialysis
- •Hepatic encephalopathy grade 3 or 4
- •Superimposed acute liver failure/injury due to factors other than alcoholic hepatitis, including acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom [Amanita] poisoning)
- •Current or recent treatment (within 7 days) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
- •Respiratory failure requiring positive airway pressure devices or intubation
- •SIRS/sepsis episode in the previous 28 days from consent
- •Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage within 28 days of consent
- •Ongoing documented or suspected infection
- •Severe cardiovascular disease that are contraindication to terlipressin therapy such as advanced arteriosclerosis, arrhythmia, coronary insufficiency or uncontrolled hypertension
- •Findings suggestive of organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive or other renal pathology)
- •Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced neoplasia, hepatocellular carcinoma [confirmed with serum alpha1-fetoprotein testing], severe chronic obstructive pulmonary disease or asthma)
- •Alcoholics who have not been abstinent for the past 6 months
- •Transjugular intrahepatic portosystemic shunt or other surgical shunt
- •For female patients: Confirmed pregnancy
- •Known allergy or hypersensitivity to terlipressin
- •Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of consent.
研究组 & 干预措施
Terlipressin acetate continuous infusion
Continuous infusion of terlipressin starting at 2 mg/day over 7 days in-house and if tolerated continue treatment in the ambulatory setting for 21 days
干预措施: Terlipressin acetate continuous infusion (Drug)
结局指标
主要结局
Steady State Plasma Levels of Terlipressin and 8-lysine Vasopressin During Terlipressin Continuous Infusion at 2 mg/Day in Cirrhotic Patients With Refractory Ascites
时间窗: 7 day treatment
Serial sampling for determination of Terlipressin concentration and metabolite 8-lysine vasopressin in plasma at steady state (Css)
Clinical Safety of Terlipressin Infusion in Cirrhotic Patients With Refractory Ascites
时间窗: 28 day treatment period and 28 day post-treatment
Rate of treatment emergent adverse events assessed by physical examination and laboratory safety
次要结局
- Change in Requirement of Large Volume Paracentesis With Continuous Infusion of Terlipressin(28 day post-treatment)