Cirrhotic ascites MedDRA version: 9.1 Level: LLT Classification code 10003445 Term: Ascites
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients that have been previously randomized and have completed the 52 weeks treatment period plus the 2 weeks post treatment follow up in any of the following studies: EFC4492; EFC4493 or EFC6682 Patients must agree to participate and sign a new inform consent specific for this study LTS10036 Patients must not have a treatment discontinuation longer than 18 days from the phases III studies treatment completion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age grade 1 by the West Haven criteria, evaluated by clinical features Known gastrointestinal bleeding currently or in the 10 days before randomisation. QTcF interval on an ECG ³480 ms. Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma Serum bilirubin >150 µmol/l INR >3.0, neutrophils 142 mmol/l Serum potassium 150 µmol/l Positive pregnancy test Females of child-bearing potential are excluded unless they meet one of the following criteria: Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test Surgical sterilisation more than one month prior to enrollment and a negative pregnancy test Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test Hormonal contraceptive in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test. Known hypersensitivity to satavaptan Administration of inducers of CYP3A listed below within the two weeks prior to study drug administration: carbamazepine, phenobarbital, phenytoin, rifampicin (rifampin), Saint John's Wort Administration within the two weeks prior to study start of the following CYP3A inhibitors, which may significantly increase exposure to the study drug. These are listed below and in Appendix C Aprepitant, chloramphenicol, clarithromycin, cremophor EL, cyclosporin, diltiazem, erythromycin, fluconazole, grapefruit juice, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil Patients taking other drugs known to increase the risk of hyperkalaemia in addition to spironolactone, potassium canrenoate or eplerenone may not be included in the study in order to avoid an additive effect on serum potassium concentrations (e.g. angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety and tolerability up to 2 years of treatment with satavaptan in patients with cirrhosis of the liver previously treated for 52 weeks with satavaptan in any of the phase III studies ;Secondary Objective: Number and time (from randomization in the previous phase III EFC studies) of therapeutic paracentesis, defined as the removal of ³ 2 liters of ascitic fluid by paracentesis. Increase in ascites measured by body weight and volume of ascites removed by paracentesis ( to be expressed as increase per unit of time to avoid any bias due to withdrawl). Diuretics regimen at each scheduled visit according to a predefined classification. ;Primary end point(s): Survival, adverse events, laboratory data, vital signs, and ECG for long term safety evaluation. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed