Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
Launched by SANG GYUNE KIM · Aug 9, 2016
Trial Information
Current as of August 26, 2025
Unknown status
Keywords
ClinConnect Summary
The measurement of liver stiffness by transient elastography (TE) has been shown to correlate with the hepatic fibrosis stage and to have considerable accuracy for the diagnosis of cirrhosis in patients with chronic hepatitis C. Previous studied reported that liver stiffness is significantly reduced in SVR patients with pegylated interferon (IFN) and ribavirin treatment. Once a patient achieve sustained virological response (SVR), and resultingly lower liver stiffness score than baseline value, it is believed that he will have a better long-term outcome due to the improvement of liver fibro...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Chronically infected with Hepatitis C virus genotype 1b
- • 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:
- • Patients with baseline key NS5A RAVs (Y93 and/or L31)
- • 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
About Sang Gyune Kim
Sang Gyune Kim is a dedicated clinical trial sponsor focused on advancing innovative medical research and therapies. With a commitment to enhancing patient outcomes, the organization collaborates with leading researchers and institutions to design and conduct rigorous clinical studies. Sang Gyune Kim emphasizes adherence to ethical standards and regulatory compliance, ensuring the safety and well-being of participants while striving to bring cutting-edge treatments to market. Through its strategic partnerships and expertise in various therapeutic areas, the sponsor aims to contribute significantly to the global healthcare landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Incheon, , Korea, Republic Of
Jung Gu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Wonju, , Korea, Republic Of
Bucheon, Gyeonggi Do, Korea, Republic Of
Cheonan, Chungcheongnam Do, Korea, Republic Of
Ansan, Gyeonggi Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Jung Gu, Incheon, Korea, Republic Of
Patients applied
Trial Officials
Sang Gyune Kim, Professor
Principal Investigator
Soonchunhyang University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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