To Assess the Effectiveness, Safety, and Tolerability of Oral Docarpamine in Patients with Refractory Ascites due to Liver Cirrhosis
- Conditions
- iver CirrhosisLiver CirrhosisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12620000211965
- Lead Sponsor
- Martin Pharmaceuticals Australia Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 20
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)
OR
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1/ Part 2: Total volume of ascetic fluid as assessed by site procedural source documentation[ Throughout the study ]
- Secondary Outcome Measures
Name Time Method