Viewing Study NCT00496158


Ignite Creation Date: 2025-12-25 @ 12:22 AM
Ignite Modification Date: 2026-01-02 @ 3:45 AM
Study NCT ID: NCT00496158
Status: TERMINATED
Last Update Posted: 2009-04-27
First Post: 2007-07-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034935', 'term': 'clevudine'}, {'id': 'C053001', 'term': 'adefovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'whyStopped': 'The study was terminated in the interest of patient safety.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-23', 'studyFirstSubmitDate': '2007-07-02', 'studyFirstSubmitQcDate': '2007-07-03', 'lastUpdatePostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus', 'hepatitis b virus'], 'conditions': ['Chronic Hepatitis', 'Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg negative hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.\n* Subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5).\n* The number of subjects entering the study with an Ishak fibrosis score of 5 will be limited to approximately 10%. If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.\n* For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.\n\nExclusion Criteria:\n\n* Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.\n* Subjects with clinically significant concomitant diseases will be excluded.'}, 'identificationModule': {'nctId': 'NCT00496158', 'acronym': 'QUASH2', 'briefTitle': 'Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmasset'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus', 'orgStudyIdInfo': {'id': 'CI-PSI-5268-06-306'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clevudine', 'type': 'DRUG'}, {'name': 'Adefovir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institution', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'West Gastroenterology Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Clemente', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.42697, 'lon': -117.61199}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy Medical Group, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Associates Research Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Ucsf/Sfgh', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'San Mateo Medical Center', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The William W. 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'state': 'New York', 'country': 'United States', 'facility': 'UMA Research Department', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'VAMC/NYU', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Gastroenterology', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97220', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Oregon Clinic P.C.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Memphis Gastroenterology Group', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Gastrointestinal Specialists, Inc', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Gastroenterology, PA', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Transplant Physicians', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77028', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Liver Therapies', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Century Clinical Research Inc', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Mecial Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 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Alende', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's", 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