Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT07128550
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D019701', 'term': 'Hepatitis D, Chronic'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718249', 'term': 'bulevirtide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24', 'timeFrame': 'Week 24'}, {'measure': 'HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.', 'timeFrame': '24 Weeks after End of Treatment'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240', 'timeFrame': 'Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240'}, {'measure': 'HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240', 'timeFrame': 'Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240'}, {'measure': 'Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240', 'timeFrame': 'Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HDV', 'Hepatitis D Virus', 'Hepatitis', 'Chronic Hepatitis D Virus', 'Hepatitis D', 'Hepatitis D, Chronic', 'Hepatitis Delta Virus', 'Digestive System Diseases', 'Liver Diseases'], 'conditions': ['Viral Hepatitis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ages 18 to 70 years at screening\n2. HDV RNA ≥ 500 IU/mL at screening\n3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1\n4. Noncirrhotic or compensated cirrhotic liver disease at screening\n5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \\< 10 IU/ml at screening, currently on locally approved NRTI therapy\n\nExclusion Criteria:\n\n1. Serum ALT ≥ 5 × ULN\n2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.\n3. History of significant liver disease from non-HBV or non-HDV etiology\n4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.\n5. History of anaphylaxis\n6. History of immune complex disease\n7. History of autoimmune disorder\n8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.'}, 'identificationModule': {'nctId': 'NCT07128550', 'briefTitle': 'A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vir Biotechnology, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)', 'orgStudyIdInfo': {'id': 'VIR-CHDV-V205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants will receive treatment with tobevibart + elebsiran up to 240 weeks.', 'interventionNames': ['Drug: Tobevibart', 'Drug: Elebsiran']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks', 'interventionNames': ['Drug: Tobevibart', 'Drug: Elebsiran', 'Drug: Bulevirtide']}], 'interventions': [{'name': 'Tobevibart', 'type': 'DRUG', 'otherNames': ['VIR-3434'], 'description': 'Tobevibart administered by subcutaneous injection', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Elebsiran', 'type': 'DRUG', 'otherNames': ['VIR-2218'], 'description': 'Elebsiran administered by subcutaneous injection', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Bulevirtide', 'type': 'DRUG', 'otherNames': ['Hepcludex'], 'description': 'Bulevirtide administered by subcutaneous injection', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '92110', 'city': 'Clichy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '78150', 'city': 'Le Chesnay', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94804', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '021105', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '022328', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030303', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '200073', 'city': 'Craiova', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': 'E1 1FR', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9NU', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Study Injury', 'role': 'CONTACT', 'email': 'clinicaltrials@vir.bio', 'phone': '415-654-5281'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}