Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
NCT ID: NCT02865369
Last Updated: 2017-03-07
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
103 participants
OBSERVATIONAL
2016-09-30
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
NCT00244751
Deciphering the Mechanisms Involved in Microbial Translocation Across the Spectrum of HCV Associated Liver Fibrosis
NCT02400216
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
NCT06750276
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
NCT01217632
A Hepatitis B With Hepatic Steatosis Study
NCT02392598
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Daclatasvir(DCV) and Asunaprevir(ASV) combined treatment showed a greater SVR rate in CHC compared to IFN based therapy. The investigators hypothesize that DCV and ASV combined treatment may achieve the improvement of liver stiffness measured by TE and a more favorable clinical outcomes in patients with advanced liver fibrosis. The investigators will also compare the change of fibrosis stage assessed by TE between this study subjects and those treated with other DAA agents during same observational period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Daclatasvir plus Asunaprevir treatment
Among patients taking Daclatasvir and Asunaprevir combined treatment and having advanced liver fibrosis assessed by transient elastography
Daclatasvir and Asunaprevir
Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daclatasvir and Asunaprevir
Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HCV RNA ≥ 10\^4 IU/mL (10,000 IU/mL)
* Chronic Hepatitis C with advanced fibrosis or cirrhosis (defined as ≥F3, ≥8 kilopascals)
* Treatment-naïve or those who previously failed to treatment with peg-interferon alfa and ribavirin
* Women of childbearing potential (WOCBP) and men, who use effective methods of birth control
Exclusion Criteria
* Estimated GFR \< 30mL/min without hemodialysis
* Alanine aminotransferase (ALT) \> 100 IU/L
* Coinfection with other hepatitis virus or human immunodeficiency virus
* A daily alcohol intake \>30 g
* Decompensated liver disease or hepatocellular carcinoma, liver or any other organ transplantation
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Boramae Hospital
OTHER
Severance Hospital
OTHER
Inha University Hospital
OTHER
Korea University
OTHER
Gachon University Gil Medical Center
OTHER
Hanyang University Seoul Hospital
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Bristol-Myers Squibb
INDUSTRY
Sang Gyune Kim
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sang Gyune Kim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sang Gyune Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Inha University Hospital
Jung-gu, Incheon, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Severance hospital
Seoul, , South Korea
Soonchunhyang University Hospital
Seoul, , South Korea
Hanyang university hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Wonju severance christian hospital
Wŏnju, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
SaeHwan Lee, Professor
Role: primary
Young Kul Jung, Professor
Role: primary
Jin-Woo Lee, Professor
Role: primary
Oh Sang Kwon, Professor
Role: primary
Jun Yong Park, Professor
Role: primary
Jae Young Jang, Professor
Role: primary
Dae Won Jun, Professor
Role: primary
Tae Hun Kim, Professor
Role: primary
Moon young Kim, Professor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506.
Hezode C, Castera L, Roudot-Thoraval F, Bouvier-Alias M, Rosa I, Roulot D, Leroy V, Mallat A, Pawlotsky JM. Liver stiffness diminishes with antiviral response in chronic hepatitis C. Aliment Pharmacol Ther. 2011 Sep;34(6):656-63. doi: 10.1111/j.1365-2036.2011.04765.x. Epub 2011 Jul 13.
Arima Y, Kawabe N, Hashimoto S, Harata M, Nitta Y, Murao M, Nakano T, Shimazaki H, Kobayashi K, Ichino N, Osakabe K, Nishikawa T, Okumura A, Ishikawa T, Yoshioka K. Reduction of liver stiffness by interferon treatment in the patients with chronic hepatitis C. Hepatol Res. 2010 Apr;40(4):383-92. doi: 10.1111/j.1872-034X.2009.00618.x. Epub 2010 Mar 4.
Wang JH, Changchien CS, Hung CH, Tung WC, Kee KM, Chen CH, Hu TH, Lee CM, Lu SN. Liver stiffness decrease after effective antiviral therapy in patients with chronic hepatitis C: Longitudinal study using FibroScan. J Gastroenterol Hepatol. 2010 May;25(5):964-9. doi: 10.1111/j.1440-1746.2009.06194.x.
Crisan D, Radu C, Grigorescu MD, Lupsor M, Feier D, Grigorescu M. Prospective non-invasive follow-up of liver fibrosis in patients with chronic hepatitis C. J Gastrointestin Liver Dis. 2012 Dec;21(4):375-82.
Bourliere, Marc, et al.
Yoo HW, Park JY, Kim SG, Jung YK, Lee SH, Kim MY, Jun DW, Jang JY, Lee JW, Kwon OS. Regression of liver fibrosis and hepatocellular carcinoma development after HCV eradication with oral antiviral agents. Sci Rep. 2022 Jan 7;12(1):193. doi: 10.1038/s41598-021-03272-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AI444-392
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.