Cirrhotic Ascites
Conditions
Brief summary
M0002, an orally active, selective non-peptidergic antagonist of the vasopressin V2 receptor inhibits vasopressin-induced water reabsorption from the kidney. Therefore the aquaretic effect of M0002 has a potential clinical benefit in the treatment of ascites and hyponatreamia in cirrhotic patients.
Interventions
DRUGM0002
DRUGPlacebo
Sponsors
Movetis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Subjects with any form of cirrhosis with ascites and who had at least 1 paracentesis of at least 4 liter in the last 6 months. 2. Dose of diuretics of spironolactone and furosemide was to be stable for at least one week prior to the screening visit or subject was refractory to diuretics. 3. Subjects had to have been on a salt restricted diet (\< 5.2 grams sodium/day, 90 mmol) during the screening period prior to the trial drug administration. 4. Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration. 5. Child-Pugh B and C liver cirrhosis score lower than 12. 6. Subjects with hyponatraemia with sodium level between 120 and 132 mmol/l or normonatraemia with sodium level between 133 and 145 mmol/l measured at screening visit and day 1. Main
Exclusion criteria
1. Women of child bearing potential (WOCBP) 2. Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt 3. Liver transplantation 4. Budd-Chiari syndrome 5. Unstable hepatic disease (acute hepatitis, AST or ALT \> 5 x upper limit of normal, bilirubin \> 10 mg/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma sodium levels, weight, number of paracentesis | 15 days |
Outcome results
None listed