Study of Efficacy of a Vasopressin 2 Receptor Antagonist M0002 for Treatment of Ascites in Cirrhotic Subjects With Hypo- or Normonatraemia

NCT01179607 | Completed Phase 2

• 1 other identifier: M0002-BEL-C201
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhotic Ascites

Outcome Measures

Primary Outcomes (1)

• Plasma sodium levels, weight, number of paracentesis

  15 days

Study Arms (2)

M0002

ACTIVE COMPARATOR

* Started at 0.3 mg/day and increased every 3 days (to 1, 3 and 6 mg/day) * for hyponatraemic subjects: dose was increased until the evening serum level was between 132 mmol/l and 145 mmol/l; * for normonatraemic subjects the dose was increased until a 500 ml increase in the 24-h urine volume compared with Day-1 was reached. Once the required response or max dose was achieved, subjects entered a maintenance phase where they remained on the same dose of M0002 or placebo until 15 days.

Drug: M0002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

M0002 DRUG

M0002

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Movetis: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 11, 2010

Record last verified: 2010-07