Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:03 AM
Study NCT ID:
NCT00892112
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2009-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D010952', 'term': 'Plasma Substitutes'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001802', 'term': 'Blood Substitutes'}, {'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2009-05-01', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunoglobulins, Intravenous', 'Cardiomyopathies', 'Parvo B19, Human'], 'conditions': ['Myocardial Diseases', 'Parvovirus B19, Human']}, 'referencesModule': {'references': [{'pmid': '33347677', 'type': 'DERIVED', 'citation': 'Hazebroek MR, Henkens MTHM, Raafs AG, Verdonschot JAJ, Merken JJ, Dennert RM, Eurlings C, Abdul Hamid MA, Wolffs PFG, Winkens B, Brunner-La Rocca HP, Knackstedt C, van Paassen P, van Empel VPM, Heymans SRB. Intravenous immunoglobulin therapy in adult patients with idiopathic chronic cardiomyopathy and cardiac parvovirus B19 persistence: a prospective, double-blind, randomized, placebo-controlled clinical trial. Eur J Heart Fail. 2021 Feb;23(2):302-309. doi: 10.1002/ejhf.2082. Epub 2021 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.', 'detailedDescription': 'Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.\n\nObjective: A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.\n\nStudy design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic cardiomyopathy (LVEF \\<45%) \\>6months\n* Optimal conventional heart failure medication \\>3 months.\n* PVB19 viral load \\>200 copies/mcg DNA in endomyocardial biopsies (EMBs).\n* Signed informed consent\n* Aged between 18 and 75 years\n\nExclusion Criteria:\n\n* Other causes for heart failure\n* Significant coronary artery disease (lesions \\>70 % stenosis)\n* Significant valvular disease\n* Untreated hypertension (blood pressure \\>140mmHg)\n* Substance abuse\n* Chemotherapy induced\n* Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)\n* Pregnancy or lactation\n* Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.\n* Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study\n* Known with allergic reactions against human plasma or plasma products\n* Having an ongoing progressive terminal disease, including HIV infection\n* Having renal insufficiency (plasma creatinin \\>115µmol/L or creatinin clearance \\<20 ml/min)\n* Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints\n* Having detectable anti-IgA antibodies\n* Active SLE'}, 'identificationModule': {'nctId': 'NCT00892112', 'briefTitle': 'Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prothya Biosolutions'}, 'officialTitle': 'Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MD2009.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous immunoglobulins', 'description': 'IV, 40 ml/kg over 4 days', 'interventionNames': ['Drug: Intravenous Immunoglobulins']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'plasma volume expander Albuman', 'description': 'IV, 40 ml/kg over 4 days', 'interventionNames': ['Drug: plasma volume expander']}], 'interventions': [{'name': 'Intravenous Immunoglobulins', 'type': 'DRUG', 'otherNames': ['Nanogam'], 'description': '2 gr/kg body weight of intravenous immunoglobulin product Nanogam® administered as 0.5 gr/kg IV over a period of 6 hours on each of 4 consecutive days', 'armGroupLabels': ['intravenous immunoglobulins']}, {'name': 'plasma volume expander', 'type': 'DRUG', 'otherNames': ['G.P.O. ("Gepasteuriseerde Plasma-eiwit Oplossing")', 'Albuman 40 g/l'], 'description': '10 ml/kg BW will be administrated on four consecutive days.', 'armGroupLabels': ['plasma volume expander Albuman']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'AZM', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'S Heymans, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZM, Maastricht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prothya Biosolutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}