Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-02 @ 6:06 AM
Study NCT ID:
NCT00968695
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2009-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-28', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To asses change from Baseline plasma renin concentration at Week 14', 'timeFrame': '14 weeks', 'description': 'Plasma renin activity will be measured at Baseline and Week 14'}, {'measure': 'To asses change from Baseline plasma renin concentration at Week 20', 'timeFrame': '20 weeks', 'description': 'Plasma renin activity will be measured at Baseline and Week 20'}, {'measure': 'To asses change from Baseline plasma concentration of noradrenaline at week 14', 'timeFrame': '14 weeks', 'description': 'Plasma noradrenaline concentration will be measured at Baseline and Week 14'}, {'measure': 'To asses change from Baseline plasma concentration of noradrenaline at Week 20', 'timeFrame': '20 weeks', 'description': 'Plasma noradrenaline concentration will be measured at Baseline and Week 20'}, {'measure': 'To assess change from Baseline glomerular filtration rate at Week 14', 'timeFrame': '14 weeks', 'description': 'Glomerular filtration rate will be measured at Baseline and Week 14'}, {'measure': 'To assess change from Baseline glomerular filtration rate at Week 20', 'timeFrame': '20 weeks', 'description': 'Glomerular filtration rate will be measured at Baseline and Week 20'}, {'measure': 'To assess change from Baseline cardiac output at Week 14', 'timeFrame': '14 weeks', 'description': 'Cardiac output will be measured at Baseline and Week 14'}, {'measure': 'To assess change from Baseline cardiopulmonary pressures at Week 14', 'timeFrame': '14 weeks', 'description': 'Cardiopulmonary pressures will be measured at Baseline and Week 14'}, {'measure': 'To assess change from Baseline free hepatic pressure at Week 14', 'timeFrame': '14 weeks', 'description': 'Free hepatic pressure will be measured at Baseline and Week 14'}, {'measure': 'To assess change from Baseline wedged hepatic pressure at Week 14', 'timeFrame': '14 weeks', 'description': 'Wedged hepatic pressure will be measured at Baseline and Week 14'}, {'measure': 'To assess change from Baseline echocardiography at Week 14', 'timeFrame': '14 weeks', 'description': 'Echocardiography will be measured at Baseline and Week 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Ascites']}, 'referencesModule': {'references': [{'pmid': '30905652', 'type': 'DERIVED', 'citation': 'Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'Effects of long term albumin administration on the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.', 'detailedDescription': 'Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years and less than 80 years.\n* Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.\n* Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide\n* Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, blood urea nitrogen ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.\n\nExclusion Criteria:\n\n* Refractory Ascites (paracentesis requirements over 1 month.\n* Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule\\> 5 cm or three nodules\\> 3 cm).\n* History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt\n* Gastrointestinal bleeding or bacterial infection documented in the past 15 days.\n* Heart failure or structural heart disease.\n* Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).\n* Moderate or severe lung chronic disease.\n* Transplant.\n* Infection with human immunodeficiency virus.\n* Active addiction to drugs.\n* Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT00968695', 'briefTitle': 'Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.', 'orgStudyIdInfo': {'id': 'IG0802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albumin', 'description': 'The subjects will be receiving albumin 20% infusions', 'interventionNames': ['Drug: Albumin']}], 'interventions': [{'name': 'Albumin', 'type': 'DRUG', 'otherNames': ['Albutein 20%'], 'description': 'The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.', 'armGroupLabels': ['Albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Vicente Arroyo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínic of Barcelona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Grifols, S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}