Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04816916
Status:
TERMINATED
Last Update Posted:
2022-07-27
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Sponsor is stopping the study to focus company resources on other development programs.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)', 'timeFrame': 'Baseline to week 24'}], 'secondaryOutcomes': [{'measure': 'Time to and frequency of recurrent overt hepatic encephalopathy', 'timeFrame': 'Baseline to week 24'}, {'measure': 'Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair)', 'timeFrame': 'Baseline to week 24'}, {'measure': 'Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Baseline to week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver cirrhosis', 'end stage liver disease', 'sarcopenia', 'amino acids'], 'conditions': ['Hepatic Encephalopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://emmpowertrial.com/', 'label': 'EMMPOWER Phase 2 Clinical Trial Homepage'}]}, 'descriptionModule': {'briefSummary': 'This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing to participate in the study and provide written informed consent.\n* Male and female adults aged ≥18 years.\n* History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.\n* A PHES of ≤ -4 during Screening.\n* MELD score of ≤ 22 at Screening.\n* Support of a primary caregiver who is able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* Hospitalization or serious medical condition.\n* Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).\n* History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Expectation of a liver transplant during the study.\n* Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study."}, 'identificationModule': {'nctId': 'NCT04816916', 'acronym': 'EMMPOWER', 'briefTitle': 'Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axcella Health, Inc'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)', 'orgStudyIdInfo': {'id': 'AXA1665-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AXA1665 53.8 g per day', 'description': 'AXA1665 administered orally TID', 'interventionNames': ['Drug: AXA1665']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'description': 'Placebo administered orally TID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AXA1665', 'type': 'DRUG', 'description': 'AXA1665 administered TID with food', 'armGroupLabels': ['AXA1665 53.8 g per day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo administered TID with food', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 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'78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia School of Medicine', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours Liver Institute', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23114', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire Research Institute, Inc., McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6A 2C2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Diabetes & Endocrinology Ltd. - London', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Kozpont', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Azienda sanitaria universitaria Friuli Centrale (ASU FC)', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'KO - MED Centra Kliniczne Lublin II', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Mysłowice', 'country': 'Poland', 'facility': 'ID Clinic', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}, {'city': 'Szczecin', 'country': 'Poland', 'facility': 'SONOMED Sp. z o.o.', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Corporacio Sanitaria Parc Tauli - Hospital de Sabadell', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'The Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Andres Duarte-Rojo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axcella Health, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}