Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-02 @ 10:34 PM
Study NCT ID:
NCT02837302
Status:
UNKNOWN
Last Update Posted:
2016-10-31
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}], 'ancestors': [{'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1470}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio', 'timeFrame': 'After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death'}], 'secondaryOutcomes': [{'measure': 'Incidence of cirrhosis-related complications including death', 'timeFrame': 'After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver cirrhosis', 'Branched chain amino acid', 'End-Stage Liver Disease score'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Protein-calorie malnutrition is frequently observed in patients with advanced liver cirrhosis. There have been continued interests in potential benefits of long-term oral branched-chain amino acid supplement in improving severity of liver disease. However, there are limited evidences in literature. The aim of this study is to evaluate the efficacy of oral branched-chain amino acid in patients with advanced liver cirrhosis.', 'detailedDescription': 'This study is a multicenter retrospective cohort study involving thirteen centers in Korea nation-wide. The inclusion criteria are liver cirrhosis patients with Child-Pugh score 8 to 10. The major exclusion criteria are abnormal serum creatinine level, and hepatocellular carcinoma with viable tumor. The investigators analyzed improvement of Model for End-Stage Liver Disease score, Child-Pugh score, incidence of cirrhosis-related complications, and event free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced liver cirrhosis patients with Child-Pugh score 8 to 10\n\nExclusion Criteria:\n\n* Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy\n* Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis\n* Patients already on a waiting list or being considered for major organ transplantation.\n* Serum creatinine above upper normal range (\\>1.5 mg/dL)\n* Patients treating with albumin replacement regularly\n* Viable hepatocellular carcinoma or advanced Barcelona Clinic Liver Cancer stage or hepatocellular carcinoma below 6 months life expectancy\n* Patients being impossible to secession of alcohol consumption\n* Patients being impossible to oral ingestion or oral medication\n* Pregnancy or being considered for pregnancy\n* Breast feeding\n* Amyotrophic lateral sclerosis\n* Patients with other metabolic disorder presenting branched-chain ketoaciduria'}, 'identificationModule': {'nctId': 'NCT02837302', 'acronym': 'BRAVE', 'briefTitle': 'Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'BRAVE_prospective'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Livact', 'description': 'Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months.', 'interventionNames': ['Drug: Livact']}, {'type': 'NO_INTERVENTION', 'label': 'General nutritional support', 'description': 'General nutritional support'}], 'interventions': [{'name': 'Livact', 'type': 'DRUG', 'otherNames': ['Branched chain amino acid'], 'description': 'Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months.', 'armGroupLabels': ['Livact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook national university hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Won Young Tak, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook national university hospital, department of internal medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Gastroenterology & Hepatology', 'investigatorFullName': 'Won Young Tak', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}