Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 2:26 PM
Study NCT ID:
NCT06251232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Prednisone medication and its placebo will be identical in appearance and in organoleptic properties.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Controlled with placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total bilirubin', 'timeFrame': 'Through study completation, an average 2 years', 'description': 'To assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.'}], 'secondaryOutcomes': [{'measure': 'Peak alanine aminotransferase level', 'timeFrame': '2 years', 'description': 'Comparison prednisone/placebo when reducing peak alanine aminotransferase (ALT), aspartate aminotransferase (AST) and international normalized ratio (INR) values by at least 50% at day 7 or reducing the time to normalisation.'}, {'measure': 'Aspartate aminotransferase level', 'timeFrame': '2 years', 'description': 'Comparison prednisone/placebo when reducing peak alanine aminotransferase (ALT), aspartate aminotransferase (AST) and international normalized ratio (INR) values by at least 50% at day 7 or reducing the time to normalisation.'}, {'measure': 'International normalized ratio values', 'timeFrame': 'Through study completation, an average 2 years', 'description': 'Comparison prednisone/placebo when reducing peak alanine aminotransferase (ALT), aspartate aminotransferase (AST) and international normalized ratio (INR) values by at least 50% at day 7 or reducing the time to normalisation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prednisone', 'Idiosyncrasic hepatotoxicity'], 'conditions': ['Hepatotoxicity', 'Idiosyncratic Drug Effect', 'Prednisone']}, 'descriptionModule': {'briefSummary': 'This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.', 'detailedDescription': 'This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value, and to assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female and male patients, aged ≥ 18 years.\n2. Patients who have been diagnosed with DILI by the expert committee.\n3. Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg/dL).\n4. Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.\n\nExclusion Criteria:\n\n1. No clear DILI diagnosis after an expert committee DILI assessment.\n2. DILI due to immune-checkpoint inhibitors.\n3. Presence of active infection as evidenced by positive urine or blood culture.\n4. Acute liver failure (international normalized ratio (INR) \\> 1.5 and hepatic encephalopathy).\n5. Model for End-Stage Liver Disease (MELD) ≥ 30.\n6. Known hypersensitivity to prednisone or placebo components.\n7. Pregnant or nursing mothers.\n8. Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).\n9. Patients already receiving systemic steroids or other immunosuppressants.\n10. Inability to provide informed consent.\n11. Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study."}, 'identificationModule': {'nctId': 'NCT06251232', 'acronym': 'DILICORT', 'briefTitle': 'Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'Proof-of-concept Phase II Study to Evaluate the Efficacy and Safety of Prednisone in the Treatment of Idiosyncratic Hepatotoxicity and Its Mechanistic Pathways Through an Integrative Analysis: the DILI-CORT Clinical Trial', 'orgStudyIdInfo': {'id': 'DILICORT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active treatment', 'description': 'Oral prednisone', 'interventionNames': ['Drug: Prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment', 'description': 'Placebo', 'interventionNames': ['Drug: Prednisone']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Comparator'], 'description': 'Placebo', 'armGroupLabels': ['Active treatment', 'Placebo treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mª Isabel Lucena, PhD', 'role': 'CONTACT', 'email': 'lucena@uma.es', 'phone': '34952131572'}, {'name': 'Gloria Luque', 'role': 'CONTACT', 'email': 'gloria.luque@ibima.eu', 'phone': '34951291977'}], 'overallOfficials': [{'name': 'Raúl Andrade, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAS'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'After 3 years', 'ipdSharing': 'YES', 'description': 'National and international webs, manuscript', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}