Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05601518
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2022-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virologic response (SVR)', 'timeFrame': '24 weeks', 'description': 'The proportion of patients with undetectable levels is detected by highly sensitive HCV RNA assay (lower limit of detection \\< 15 IU/mL)'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '24 weeks', 'description': 'Record AEs during the study (observe and record at any time).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatitis C infection'], 'conditions': ['Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '26111063', 'type': 'BACKGROUND', 'citation': 'AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology. 2015 Sep;62(3):932-54. doi: 10.1002/hep.27950. Epub 2015 Aug 4. No abstract available.'}, {'pmid': '29380415', 'type': 'BACKGROUND', 'citation': 'Wei L, Xie Q, Hou JL, Jia J, Li W, Xu M, Li J, Wu S, Cheng J, Jiang J, Wang G, Yang Y, Mou Z, Gao ZL, Gong G, Niu JQ, Hu P, Tang H, Lin F, Dou X, Li L, Zhang LL, Nan Y, Massetto B, Yang JC, Knox SJ, Kersey K, German P, Mo H, Jiang D, Brainard DM, Jiang J, Ning Q, Duan Z. Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China. J Gastroenterol Hepatol. 2018 Jun;33(6):1168-1176. doi: 10.1111/jgh.14102. Epub 2018 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.\n\nThe development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.\n\nTreatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:\n\nCoblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).\n\nCoblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'chronic hepatitis C infection (positive serum anti-HCV antibodies, detection of HCV RNA in serum)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic hepatitis C infection\n2. Age 18 years and over\n3. Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;\n\nExclusion Criteria:\n\n1. Patients who are receiving other DAAs drugs at the same time;\n2. Subjects with poor compliance who are unable to complete treatment or follow-up.'}, 'identificationModule': {'nctId': 'NCT05601518', 'briefTitle': 'Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.', 'orgStudyIdInfo': {'id': '22408-0-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Group Assignment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Bejing', 'country': 'China', 'facility': 'Bejing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lai Wei, MD', 'role': 'CONTACT', 'email': 'weilai@mail.tsinghua.edu.cn', 'phone': '+86-1056118881'}, {'name': 'Feng Xue', 'role': 'CONTACT', 'email': 'xuef21@mails.tsinghua.edu.cn', 'phone': '+86-18810799293'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}