Chronic hepatitis C
Conditions
Interventions
Genotype 1 and 4, fibrosis stage F0-F4
Daclatasvir + sofosbuvir
12 weeks
Genotype 3, fibrosis stage F0-F3
Daclatasvir + sofosbuvir + ribavirin
12 weeks
Genotype 3, fibrosis stage F4
Daclatasvi
Sponsors
AMC
Eligibility
Inclusion criteria
Inclusion criteria: - Subjects infected with HCV genotype 1, 3 or 4. - Subjects who are treatment-naïve to or relapsed after any previous antiviral therapy other than combination of sofosbuvir + NS5A inhibitor ± ribavirin - Age: 18 - 65 years - Males, or post-menopausal or hysterectomized females
Exclusion criteria
Exclusion criteria: - Women of childbearing potential - Other known cause of liver disease except for CHC - History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, or other signs of hepatic insufficiency or portal hypertension - History of hepatocellular carcinoma on imaging studies or serum alpha-fetoprotein (AFP) > 50 ng/mL at screening - Concurrent clinically significant medical diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune response: o Baseline versus end-of-treatment versus follow-up o Patients with SVR versus patients with non-SVR o Patients with genotype 1 versus 3 versus 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| - SVR12 in the study population - Proportion of patients with HCV RNA < LLOD at 4 and 24 weeks after cessation of therapy - Proportion of patients with HCV RNA < LLOD at week 4 during treatment - Any AE leading to discontinuation of the study drug | — |
Contacts
Public ContactMeike van der Ree
Meibergdreef 9 Kamer: G4-214
Outcome results
None listed