Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 8:21 PM
Study NCT ID:
NCT01441804
Status:
UNKNOWN
Last Update Posted:
2013-10-01
First Post:
2011-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-28', 'studyFirstSubmitDate': '2011-09-24', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (SVR)', 'timeFrame': '24 weeks after the end of treatment', 'description': 'Undetectable HCVRNA in serum(\\<15IU/ml) 24 weeks after the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment', 'timeFrame': 'baseline, 24 weeks after the end of treatment'}, {'measure': 'Sick leave in patients treated for 24 or 48 weeks treatment', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Serum Hepatitis C RNA \\> 10,000IU/mL\n* Hepatitis C virus genotype 1\n* IL28B CC polymorphism\n\nExclusion Criteria:\n\n* Previous treatment for chronic Hepatitis C\n* clinical or biological evidence of acute hepatitis, including serum ALT or AST \\> 300U/ml\n* HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease\n* Contraindications to PR-based treatment:\n\n * Uncontrolled psychiatric illness\n * Active substance dependency\n * Known autoimmune disorder\n * Untreated thyroid disease\n * Uncontrolled seizure disorder\n * Pregnancy, lactation or inability to maintain contraception\n * Chronic kidney disease w/ estimated GFR\\< 60\n * ANC\\<1.5/nl, Hb\\<12g/dl, or platelets\\<75/nl\n* Clinical or biochemical evidence of decompensated liver disease including:\n\n * History of encephalopathy\n * Ascites\n * Variceal bleeding\n * Bilirubin \\> 3g/dl or INR \\> 1.5\n * Life threatening disorder with expected median survival less than 5 years\n * Inability to comply with drug regimens or testing schedule required for study'}, 'identificationModule': {'nctId': 'NCT01441804', 'briefTitle': 'A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'orgStudyIdInfo': {'id': 'TAHG1IL-28BCC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24-Week treatment group', 'description': 'Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks', 'interventionNames': ['Drug: Peginterferon alfa2a', 'Drug: Ribavirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '48-Week treatment group', 'description': 'Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks', 'interventionNames': ['Drug: Peginterferon alfa2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Peginterferon alfa2a', 'type': 'DRUG', 'description': 'patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks', 'armGroupLabels': ['24-Week treatment group']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks', 'armGroupLabels': ['24-Week treatment group']}, {'name': 'Peginterferon alfa2a', 'type': 'DRUG', 'description': 'patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks', 'armGroupLabels': ['48-Week treatment group']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks', 'armGroupLabels': ['48-Week treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Fengjuan, Doctor', 'role': 'CONTACT', 'email': 'fengjuandj@163.com', 'phone': '13416167557'}, {'name': 'Xu Min, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Eighth People's Hospital of Guangzhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cai Qingxian, doctor', 'role': 'CONTACT', 'email': 'Cqx200000@163.com', 'phone': '13760857996'}, {'name': 'Zhang Xiaohong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lin Chaoshuang, doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Third Affliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huang mingshou, Bachelor', 'role': 'CONTACT', 'phone': '+86013711033556'}, {'name': 'Huang mingshou, Bachelor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Panyu People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei min, Doctor', 'role': 'CONTACT', 'phone': '+86013702528182'}, {'name': 'Wei min, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Zhongshan second people's hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'centralContacts': [{'name': 'Cai Qingxian, doctor', 'role': 'CONTACT', 'email': 'cqx200000@163.com', 'phone': '+86013760857996'}, {'name': 'Zhao Zhixin, doctor', 'role': 'CONTACT', 'email': 'zxzhao@21cn.com', 'phone': '+86013527873714'}], 'overallOfficials': [{'name': 'Gao Zhiliang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'The Third Affliated Hospital of Sun Yat-sen University'}, {'name': 'Zhao Zhixin, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Third Affliated Hospital of Sun Yat-sen University'}, {'name': 'Zhang Xiaohong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Affliated Hospital of Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Third Affiliated Hospital, Sun Yat-Sen University', 'investigatorFullName': 'Cai Qingxian', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}