Satavaptan Cirrhotic Ascites Treatment Study a double-blind, randomised, parallel-group comparison of treatment with satavaptan at 5 to 10 mg daily versus placebo on top of conventional treatment in patients with ascites due to cirrhosis of the liver - CATS
- Conditions
- cirrhotic ascitesMedDRA version: 9.1Level: LLTClassification code 10003445Term: Ascites
- Registration Number
- EUCTR2006-000132-27-IT
- Lead Sponsor
- Sanofi-Synthelabo Recherche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
Patients with cirrhosis of the liver confirmed by histology and/or a combination of either ultrasound or endoscopic examination with laboratory evidence e.g. low platelet count, low serum albumin, elevated total serum bilirubin or elevated INR . - Patients with clinically evident ascites primarily managed by diet and/or diuretics Patients should have a physical exam compatible with diagnosis of ascites e.g. abdominal distension with confirmation of ascites either by ultrasound or presence of at least one of the following signs fluid wave, shifting dullness, bulging flanks lying supine, tympany at the top of the abdominal curve while supine, or presence of Puddle sign confirmed by ultrasound or diagnostic paracentesis. - Stable treatment of ascites for at least the previous 2 weeks without paracentesis - Patients having undergone no more than one therapeutic paracentesis in the previous 6 months.
Are the trial subjects under 18? yes
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
1 Related to study methodology Age 18 years No written informed consent Inability to follow verbal and written instructions. Patients with an existing functional TIPS transjugular intrahepatic portosystemic shunt or other shunt designed to transfer blood from the portal system to the systemic circulation bypassing the liver. Budd-Chiari syndrome Patients with positive HBV DNA who have started antiviral treatment in the previous 4 weeks or in whom such treatment is planned to start during the next 12 weeks. Previous liver transplantation Known hepatocellular carcinoma unless only one lesion 5 cm diameter or no more than 3 nodules of 3 cm . Sepsis or spontaneous bacterial peritonitis currently or in the 10 days before randomisation. Current hepatic encephalopathy grade 1 by the West Haven criteria, Appendix B evaluated by clinical features Known gastrointestinal bleeding currently or in the 10 days before randomisation. QTcF interval on an ECG 480 ms. Patients with ascites of cardiac origin or due to peritoneal infection e.g. tuberculosis or peritoneal carcinoma Serum bilirubin 150 mol/l INR 3.0, neutrophils 1 000/mm3, platelets 30 000/mm3. Patients previously exposed to satavaptan in the past 12 months 2 Related to satavaptan Haemodynamic insufficiency systolic arterial pressure 80 mmHg or symptomatic orthostatic hypotension Serum sodium 142 mmol/l Serum potassium 5.0 mmol/l Significant renal impairment with serum creatinine 150 mol/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 for more than one month duration and a negative pregnancy test - Intrauterine device in combination with a secondary barrier e.g. diaphragm, condom or spermicide and a negative pregnancy test - Oral 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 of potent and moderate inhibitors of CYP3A, which may significantly increase exposure to the study drug, within the two weeks prior to study drug administration. These are listed below and in Appendix E - Aprepitant, atazanavir, chloramphenicol, clarithromycin, cremophor EL, cyclosporine, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method