Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sang Gyune Kim
• Collaborators: Bristol-Myers Squibb; Ewha Womans University Mokdong Hospital; Gachon University Gil Medical Center; Hanyang University Seoul Hospital; Inha University Hospital; Korea University; Seoul National University Boramae Hospital; Severance Hospital
• Treatments: Asunaprevir

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