Status:
COMPLETED
Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia
Lead Sponsor:
Movetis
Conditions:
Cirrhotic Ascites
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ha...
Eligibility Criteria
Inclusion
- Main
- 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.
- 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.
- 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.
- Other treatment for the management of cirrhosis and ascites should be stable for at least 2 weeks prior to trial drug administration.
- Child-Pugh B and C liver cirrhosis score lower than 12.
- 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
- Women of child bearing potential (WOCBP)
- Functional transjugular intrahepatic portasystemic stent shunt (TIPS), peritoneovenous shunt
- Liver transplantation
- Budd-Chiari syndrome
- Unstable hepatic disease (acute hepatitis, AST or ALT \> 5 x upper limit of normal, bilirubin \> 10 mg/dL)
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01179607
Start Date
June 1 2007
End Date
December 1 2007
Last Update
August 11 2010
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