Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-08 @ 6:57 PM
Study NCT ID:
NCT03947034
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022124', 'term': 'Hyperammonemia'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}], 'secondaryOutcomes': [{'measure': 'Causality assessment of reported metabolic toxicities events according to the WHO system', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the type of metabolic toxicity depending on the category of drug', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the duration of treatment when the toxicity happens (role of cumulative dose)', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the drug-drug interactions associated with adverse events', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the pathologies (cancer) for which the incriminated drugs have been prescribed', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}, {'measure': 'Description of the population of patients having hematological toxicity adverse event', 'timeFrame': 'to 01/05/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperammonemia', 'Metabolic Disease', 'Adverse Drug Event', 'Drug Toxicity']}, 'descriptionModule': {'briefSummary': 'Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).', 'detailedDescription': 'Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients treated with a drug that could be reported in the WHO's pharmacovigilance database", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Case reported in the WHO's pharmacovigilance database till 01/05/2019\n\nExclusion Criteria:\n\n* Chronology not compatible between the drug and the toxicity"}, 'identificationModule': {'nctId': 'NCT03947034', 'acronym': 'AmmoTOX', 'briefTitle': 'Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)', 'orgStudyIdInfo': {'id': 'CIC1421-19-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metabolic toxicity induced by drugs and chemotherapies', 'description': 'Case reported in the World Health Organization (WHO) of metabolic toxicities(such as hyperammonemia) of patient treated by a drug, with a chronology compatible with the drug toxicity', 'interventionNames': ['Drug: Drugs inducing hyperammonemia']}], 'interventions': [{'name': 'Drugs inducing hyperammonemia', 'type': 'DRUG', 'description': 'Drugs susceptible to induce metabolic toxicities such as hyperammonemia', 'armGroupLabels': ['Metabolic toxicity induced by drugs and chemotherapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant director, clinical investigation center Paris Est', 'investigatorFullName': 'Joe Elie Salem', 'investigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'}}}}