Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT01755403
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009999', 'term': 'benzonidazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-25', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Population pharmacokinetic parameters of Benznidazole', 'timeFrame': '2 months (treatment period)', 'description': 'Population pharmacokinetic model development'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': '2 months (treatment period)', 'description': 'Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chagas Disease']}, 'referencesModule': {'references': [{'pmid': '29351667', 'type': 'DERIVED', 'citation': "Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516."}, {'pmid': '25824212', 'type': 'DERIVED', 'citation': 'Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.\n* Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.\n* Any gender.\n* All the participants must agree to participate in the study and must sign the informed consent.\n\nExclusion Criteria:\n\n* Patients younger than 18.\n* Patients with previous hypersensitivity to Benznidazole.\n* Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.\n* Hepatic dysfunction\n* Renal dysfunction: serum creatinin higher than 3 mg/dl.\n* Pregnancy or lactation.\n* Low adhesion to treatment or check-up.\n* Impossibility of follow-up.\n* Severe adverse reaction to Benznidazole.\n* Any other situation that could be risky for the patient.'}, 'identificationModule': {'nctId': 'NCT01755403', 'acronym': 'CINEBENZ', 'briefTitle': 'Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease', 'organization': {'class': 'OTHER', 'fullName': 'Barcelona Centre for International Health Research'}, 'officialTitle': 'Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.', 'orgStudyIdInfo': {'id': 'CINEBENZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Benznidazole', 'interventionNames': ['Drug: Benznidazole']}], 'interventions': [{'name': 'Benznidazole', 'type': 'DRUG', 'armGroupLabels': ['Benznidazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'International Health Department, Hospital Clinic, Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Joaquim Gascón, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barcelona Centre for International Health Research (CRESIB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barcelona Centre for International Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}