Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-02 @ 12:20 AM
Study NCT ID:
NCT00366795
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2006-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Israel', 'Serbia and Montenegro', 'Slovakia', 'Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103281', 'term': 'satavaptan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'whyStopped': 'Study was terminated due to safety reason.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2006-08-18', 'dispFirstSubmitQcDate': '2016-04-18', 'studyFirstSubmitQcDate': '2006-08-18', 'dispFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and time of recurrences of therapeutic paracenteses', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Time from randomisation to first recurrence of ascites', 'timeFrame': 'study period'}, {'measure': 'Increase in ascites', 'timeFrame': 'over 12 weeks'}]}, 'conditionsModule': {'conditions': ['Ascites', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '21836029', 'type': 'DERIVED', 'citation': 'Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'Primary:\n\nTo evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.\n\nSecondary:\n\nTo evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.\n\nThe one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cirrhosis of the liver.\n* Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.\n* Patients with recurrent ascites having undergone both of the following:\n\n * therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or \\> 4 litres of fluid.\n * at least one other therapeutic paracentesis in the previous 3 months.\n\nExclusion Criteria:\n\n* Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.\n* Known hepatocellular carcinoma.\n* Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma\n* Patients previously exposed to satavaptan in the past 12 months.'}, 'identificationModule': {'nctId': 'NCT00366795', 'acronym': 'SPARe-2', 'briefTitle': 'Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.', 'orgStudyIdInfo': {'id': 'EFC6682'}, 'secondaryIdInfos': [{'id': 'EudraCT : 2006-000132-27'}, {'id': 'LTS10036'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Satavaptan', 'interventionNames': ['Drug: Satavaptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Satavaptan', 'type': 'DRUG', 'otherNames': ['SR121463B'], 'description': 'oral administration once daily', 'armGroupLabels': ['Satavaptan']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral administration once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19355', 'city': 'Malvern', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.03622, 'lon': -75.51381}}, {'city': 'San Isidro', 'country': 'Argentina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -34.46971, 'lon': -58.52111}}, {'city': 'Macquarie Park', 'country': 'Australia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}