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.
NCT ID: NCT05601518
Last Updated: 2022-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
450 participants
OBSERVATIONAL
2022-11-01
2023-12-31
Brief Summary
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The 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.
Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:
Coblopasvir 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%).
Coblopasvir 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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Single Group Assignment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years and over
3. Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;
Exclusion Criteria
2. Subjects with poor compliance who are unable to complete treatment or follow-up.
18 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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Locations
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Bejing Tsinghua Changgung Hospital
Beijing, Bejing, China
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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22408-0-03
Identifier Type: -
Identifier Source: org_study_id
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