Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT00165633
Status:
TERMINATED
Last Update Posted:
2008-12-09
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030814', 'term': 'menatetrenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-05', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival period.', 'timeFrame': 'Every 3 months'}]}, 'conditionsModule': {'keywords': ['Hepatocellular', 'Carcinoma', 'Hepatitis C Virus', 'Hepatitis B Virus', 'recurrence', 'Vitamin K2', 'E0167'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the superiority of inhibitory effects and safety of Menatetrenone (E0167) on recurrence in patients with hepatocellular carcinoma.', 'detailedDescription': 'The study was conducted as a multicenter, randomized, parallel, placebo-controlled, double-blind comparative clinical study. Patients were randomly assigned in a double-blind manner to receive 45 or 90 mg/day of oral vitamin K2 or an identical-appearing placebo. Study drug was administered orally three times daily after meals until recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20 years or older at the time of obtaining consent.\n2. Systemic conditions are 0 to 2 score of Performance Status (according to Eastern Cooperative Oncology Group: ECOG).\n3. Diagnosis of hepatocellular carcinoma is based on the following 1) or 2).\n\n * 1\\) Patients who are confirmed to have early tumor stain and typical finding(s) of hepatocellular carcinoma with CT or MRI imaging\n * 2\\) Patients who underwent tumor biopsy and are histopathologically diagnosed as hepatocellular carcinoma\n4. Primary onset or recurrence of hepatocellular carcinoma is not more than 1 time.\n5. Patients who underwent the following 1) or 2) within 90 days prior to registration to determine therapeutic effect.\n\n * 1\\) Patients who underwent local therapy to achieve complete hepatonecrosis and are confirmed to have complete hepatonecrosis with CT imaging or MRI.\n * 2\\) Patients who underwent surgical treatment(s) and are confirmed not to have residual tumor with CT or MRI imaging.\n6. Patients who meet the following items to determine liver function:\n\n * 1\\) Albumin is 2.8 g/dL or above\n * 2\\) Total bilirubin is under 2.0 mg/dL\n * 3\\) Prothrombin activation is 40% or above\n7. Patients who are given full explanation of study participation (including cancer notification) and submit written consent forms with their understanding as well as voluntary will for this study.\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma:\n\n * 1\\) Patients who have extrahepatic metastasis\n * 2\\) Patients who have portal invasion\n * 3\\) Patients who experienced with systemic administration of anti-malignant tumor drugs to treat hepatocellular carcinoma\n * 4\\) Patients treated with transcatheter arterial chemoembolization (TAE) alone as a non-local therapy for hepatocellular carcinoma\n2. Hepatitis:\n\n \\-- 1) Patients of (a) or (b) previously treated with interferon preparations (including clinical studies).\n * (a) Patients with chronic hepatitis C virus (HCV) showing HCV-RNA negative\n * (b) Patients with viral hepatitis treated with interferon preparations within the last 2 years (from the same day, 6 months earlier to the day of obtaining consent forms)\n * (c) Patients with encephalopathy in which pharmacotherapy is ineffective\n * (d) Patients with ascites or pleural effusion that cannot be managed with diuretics\n3. Systemic conditions:\n\n * 1\\) Patients unable to receive oral administration\n * 2\\) Patients with a history of gastrectomy or extensive resection of digestive tract\n * 3\\) Patients who are suspected to have biliary occlusion, choleretic disorder, cholecystectomy, or malabsorption of liposoluble agents\n * 4\\) Patients with complicated serious diseases such as cardiovascular (e.g., myocardial infarction), hematological (e.g., aplastic anemia), and/or renal dysfunctions (e.g., acute and chronic renal failure)\n * 5\\) Patients with multiple cancers (within a 5-year cancer-free period \\[from the same day of 5 years earlier to the day of obtaining consent forms\\])\n4. Drug administration:\n\n * 1\\) Patients on warfarin potassium therapy\n * 2\\) Patients with a known history of drug allergy to E0167 or its ingredients\n * 3\\) Patients who received vitamin K preparations within the recent 6 months (from the same day of 6 month earlier to the day of obtaining consent forms)\n5. Other exclusion criteria\n\n * 1\\) Women of pregnant, lactating, childbearing potential, or with the intention of becoming pregnant\n * 2\\) Patients who are presently participating in another clinical study (except for follow-up surveys for study outcomes)\n * 3\\) Patients who are judged to be ineligible for study entry by the investigator or subinvestigator'}, 'identificationModule': {'nctId': 'NCT00165633', 'briefTitle': 'A Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Phase II/III Clinical Study on Inhibitory Effects of E0167 on Recurrence of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'E0167-J081-551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Menatetrenone']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Menatetrenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Menatetrenone', 'type': 'DRUG', 'otherNames': ['E0167'], 'description': '45 mg capsule, orally, three times a day, after meals.', 'armGroupLabels': ['1']}, {'name': 'Menatetrenone', 'type': 'DRUG', 'otherNames': ['E0167'], 'description': '90 mg capsule, orally, three times a day, after meals.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule, orally, three times a day, after meals.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '814-0133', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '830-0011', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '730-001', 'city': 'Naka', 'state': 'Hiroshima', 'country': 'Japan'}, {'zip': '006-8111', 'city': 'Sapporo', 'state': 'Hokkaido-prefecture', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido-prefecture', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '317-0077', 'city': 'Hitachi', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 140.65}}, {'zip': '020-0023', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '213-0001', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '920-0934', 'city': 'Kanazawa', 'state': 'Kanazawa-prefecture', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '980-0872', 'city': 'Senndai', 'state': 'Miyagi', 'country': 'Japan'}, {'zip': '951-8122', 'city': 'Niigata', 'state': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '879-5503', 'city': 'Ōita', 'state': 'Oita Prefecture', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'zip': '710-0052', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '700-0013', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '700-0014', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '570-0074', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'zip': '537-0025', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '543-0021', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '543-0027', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '589-0014', 'city': 'Sayama', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.51685, 'lon': 135.56298}}, {'zip': '840-0054', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '849-0937', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '420-0881', 'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '113-0033', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '101-0024', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '158-0098', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '151-0053', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '162-0052', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '641-0012', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '755-0046', 'city': 'Ube', 'state': 'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}], 'overallOfficials': [{'name': 'Nozomu Koyanagi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Customer Information Services Department. CRC and QA', 'oldOrganization': 'Eisai Company Limited'}}}}