Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT05900050
Status:
TERMINATED
Last Update Posted:
2025-10-29
First Post:
2023-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Liver Failure Consortium (CLIF-C) ACLF score at Day 7', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Time to death through Days 28 and 90', 'timeFrame': 'Day 1 through Days 28 and 90'}, {'measure': 'Change in ACLF grade through/at Days 7 and 28', 'timeFrame': 'Day 1 through Day 7 and Day 28, at Days 7 and 28'}, {'measure': '28-day and 90-day mortality', 'timeFrame': 'At Days 28 and 90'}, {'measure': 'Transplant-free survival through/at Days 28 and 90', 'timeFrame': 'Day 1 through Days 28 and 90, at Day 28 and 90'}, {'measure': 'Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.', 'timeFrame': 'Day 0 to Day 90', 'description': 'Safety'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic liver diseases', 'Hepatic Dysfunction', 'Extrahepatic Organ Dysfunction', 'Liver Failure', 'Renal Disease', 'Hepatic Impairment', 'Renal Impairment', 'Hepatic Decompensation', 'Cirrhosis'], 'conditions': ['Acute-On-Chronic Liver Failure', 'Ascites']}, 'descriptionModule': {'briefSummary': 'A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;\n2. Onset of ACLF not more than 14 days before Baseline (BL);\n3. Presence of ascites requiring diagnostic or therapeutic paracentesis;\n4. Patients with dry body weight ≥40 and \\<140 kg;\n5. Written informed consent obtained prior to the start of any study-related procedures.\n\nExclusion Criteria:\n\n1. Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores:\n\n 1. Respiratory failure necessitating invasive mechanical ventilation;\n 2. Coagulation failure (INR \\> 3.2 or platelet count ≤20 x 109/L);\n 3. Severe cardiovascular failure requiring the use of high dose vasopressors;\n2. ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria;\n3. Presence of spontaneous or secondary bacterial peritonitis;\n4. Presence of uncontrolled severe infection(with hemodynamic instability or shock);\n5. Poorly controlled seizure disorder;\n6. Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL;\n7. Contraindication for paracentesis;\n8. Coagulation disorders such as disseminated intravascular coagulation or hemophilia;\n9. Potential or known hypersensitivity to liposomes;\n10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;\n11. Patients after organ transplantation receiving immunosuppressive medication;\n12. Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs;\n13. Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);\n14. Alfapump® in place to manage ascites;\n15. Pregnancy and lactation;\n16. Women of child-bearing potential who are not willing to use adequate contraception;\n17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.'}, 'identificationModule': {'nctId': 'NCT05900050', 'briefTitle': 'Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': 'A Phase 2a, Open-label, Randomized, Controlled, Multi-center Proof of Concept Study to Assess the Efficacy, Safety, and Tolerability of VS-01 on Top of Standard of Care, Compared to Standard of Care Alone, in Adult Patients With Acute-on-chronic Liver Failure (ACLF)', 'orgStudyIdInfo': {'id': 'VS01-IIa-01'}, 'secondaryIdInfos': [{'id': '2024-513706-56-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VS-01 on top of SOC (Active Treatment Group)', 'description': 'Patients randomized to Active Treatment group will receive VS-01 on top of SOC', 'interventionNames': ['Drug: VS-01 on top of SOC']}, {'type': 'OTHER', 'label': 'SOC (Control Group)', 'description': 'Patients randomized to Control group will receive SOC defined as the standard medical management of patients with decompensated cirrhosis and ACLF', 'interventionNames': ['Other: SOC (Control Group)']}], 'interventions': [{'name': 'VS-01 on top of SOC', 'type': 'DRUG', 'description': 'Patients will receive VS-01 intraperitoneally on four consecutive days on top of SOC', 'armGroupLabels': ['VS-01 on top of SOC (Active Treatment Group)']}, {'name': 'SOC (Control Group)', 'type': 'OTHER', 'description': 'Patients will receive SOC for decompensated cirrhosis and ACLF', 'armGroupLabels': ['SOC (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Atlanta Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health Care', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/ New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Liver Institute at Methodist Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Tours', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Universitaire Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitatsklinikum Munster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Központ', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3300', 'city': 'Eger', 'country': 'Hungary', 'facility': 'Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet', 'geoPoint': {'lat': 47.90265, 'lon': 20.37329}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00185', 'city': 'Roma', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Policlinico Umberto I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Katharina Staufer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Versantis AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Versantis AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}