ACTRN12620000211965终止2 期
A Phase 2a Open-Label Study Assessing the Effectiveness, Safety, and Tolerability of OralDocarpamine in Patients with Refractory Ascites due to Liver Cirrhosis
Martin Pharmaceuticals Australia Pty Ltd.0 个研究点目标入组 20 人开始时间: 2020年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •For Part A and Part B:
- •1. Patients 18 years to 70 years of age.
- •2. Documented cirrhosis of the liver.
- •3. Refractory ascites, defined as ascites not manageable with diuretics and diet restriction, managed with periodic large volume therapeutic paracentesis.
- •4. Patients must have a documented minimum of 2 therapeutic paracenteses in the 60 days prior to enrollment (V0), with an anticipated minimum of 3 paracentesis in the 90 days prior to the start of study treatment on Day 1 (V1) (Part A)
- •Patients must have had regular paracentesis over the previous 9 weeks prior to study entry, with a documented minimum of 2 therapeutic paracenteses in the 9 weeks prior to the start of study (Part B)
- •5. Outpatient, with expected survival of at least 6 months.
- •6. Willing and able to complete an informed consent form.
排除标准
- •For Part A and Part B:
- •1. Ascites due to any cause other than cirrhosis such as malignant ascites.
- •2. Existing or planned placement of transjugular intrahepatic portosystemic shunt (TIPS) or other surgical shunts.
- •3. Active bacterial infection.
- •4. Scheduled organ transplantation within the next 6 months.
- •5. Anticipated change in diuretics schedule within 30 days prior to V1.
- •6. Model for End-Stage Liver Disease-Sodium (MELD-Na) Score of > 25 (based on the most recent bloodwork per medical records and within 30 days of V0).
- •7. Serum creatinine > 2 mg/dL (based on the most recent bloodwork per medical records).
- •8. Serum bilirubin > 5 mg/dL (based on the most recent bloodwork per medical records)
- •9. International normalized ratio (INR) > 2.0 (based on the most recent bloodwork per medical records).
- •10. Hepatocellular Carcinoma Barcelona Clinic Liver Cancer (BCLC) stage C or above.
- •11. Current or recent (within 3 months of consent) renal dialysis.
- •12. Hepatic encephalopathy grade 3 or 4.
- •13. Pheochromocytoma or hypertrophic obstructive cardiomyopathy.
- •14. Current or recent treatment (within 7 days of V0 dosing) with octreotide, midodrine, vasopressin, dopamine or other vasopressors.
- •15. Current or recent treatment (within 21 days of V0 dosing) with monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, phenytoin, haloperidol or haloperidol-like drugs, or phenothiazines such as prochlorperazine.
- •16. Episode of spontaneous bacterial peritonitis or gastrointestinal hemorrhage, or any acute decompensation within 30 days of enrollment (V0).
- •17. Severe cardiovascular disease such as Congestive Heart Failure (CHF), advanced arteriosclerosis, coronary insufficiency, tachyarrhythmia, or uncontrolled hypertension above 160/100.
- •18. Known or suspected extra-hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for at least 3 years.
- •19. Pregnant females, females anticipating pregnancy during study period, or breastfeeding.
- •20. Known allergy or hypersensitivity to dopamine or docarpamine (DCP).
- •21. Any severe comorbidity that in the opinion of the Investigator would disallow safe participation in the trial.
- •22. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 90 days of consent.
- •23. Type 1 hepatorenal syndrome (Part B)
- •24. Untreated or uncontrolled large (F3) esophageal varices that in the opinion of the Investigator would disallow safe participation in the trial (Part B).
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