Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT06397859
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003699', 'term': 'Hepatitis D'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718249', 'term': 'bulevirtide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 266}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate the virological response rate to BLV', 'timeFrame': 'Week 96', 'description': 'Percentage of patients with \\>2 Log decline in HDV-RNA (IU/mL)'}, {'measure': 'Investigate the virological response rate to BLV', 'timeFrame': 'Week 96', 'description': 'Percentage of patients with undetectable HDV-RNA (IU/mL)'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)', 'timeFrame': 'Week 96', 'description': 'Percentage of patients with \\>2 Log decrease in HDV-RNA along with normalization of ALT (combined response)'}, {'measure': 'Evaluation of the percentage of patients with normal ALT', 'timeFrame': 'Week 96', 'description': 'Percentage of patients with normal ALT'}, {'measure': 'Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA', 'timeFrame': 'Week 96', 'description': 'Percentage of patients with \\< 1 log decline HDV RNA levels'}, {'measure': 'Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.', 'timeFrame': 'Week 96', 'description': 'Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;'}, {'measure': 'Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response', 'timeFrame': 'Week 96', 'description': 'Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV'}, {'measure': 'Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)', 'timeFrame': 'Year 5', 'description': 'Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5'}, {'measure': 'Evaluation of bile acids levels over time and correlation of bile levels with virological response rates', 'timeFrame': 'Week 96', 'description': 'Correlation between bile acids levels and virological response over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis D']}, 'descriptionModule': {'briefSummary': 'Retrospective and prospective, pharmacological, multicentre, non-profit observational study.\n\nConsecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.\n\nAim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.\n\nPrimary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ageā„18 years\n* HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis\n* Started treatment with BLV monotherapy between September 1st 2019 and 2025\n\nExclusion Criteria:\n\n* Chronic hepatitis without any evidence of cirrhosis\n* Decompensated cirrhosis\n* PegIFN alpha therapy'}, 'identificationModule': {'nctId': 'NCT06397859', 'acronym': 'SAVE-D', 'briefTitle': 'Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)', 'orgStudyIdInfo': {'id': 'IN-IT-589-7118'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatis Delta', 'description': 'Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously', 'interventionNames': ['Drug: Bulevirtide']}], 'interventions': [{'name': 'Bulevirtide', 'type': 'DRUG', 'otherNames': ['Hepcludex'], 'description': 'dose of 2 mg/day subcutaneously', 'armGroupLabels': ['Hepatis Delta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Lampertico, MD', 'role': 'CONTACT', 'email': 'pietro.lampertico@unimi.it', 'phone': '0255035432'}], 'facility': "Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}